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# Regen Report

B2B Publication on Regenerative Medicine and Stem Cells

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## Posts

- [Vyriad Begins Mayo Clinic CAR-T Phase 1 for Multiple Myeloma](https://theregenreport.com/2026/09/14/vyriad-begins-mayo-clinic-car-t-phase-1-for-multiple-myeloma/) - Up to 40 patients with relapsed or refractory multiple myeloma may enroll to test an approach designed to generate engineered T cells inside the body. - The Regen Report
- [FDA Clears AbelZeta's CAR-T Trial for Progressive MS](https://theregenreport.com/2026/09/14/fda-clears-abelzetas-car-t-trial-for-progressive-ms/) - The multicenter study will begin with 6 to 24 participants to select a dose, followed by about 95 participants divided into two disease-pattern cohorts. - The Regen Report
- [Mesenchymal Stem Cell Extracellular Vesicles Reprogram Microglia and Prevent Neurodegeneration in Alzheimer’s Models](https://theregenreport.com/2026/09/14/mesenchymal-stem-cell-extracellular-vesicles-reprogram-microglia-and-prevent-neurodegeneration-in-alzheimers-models/) - Researchers administered the vesicles intranasally over time to female mice genetically engineered to model Alzheimer’s and separately tested them in neurons grown from patients’ induced pluripotent stem cells. - The Regen Report
- [Fate Therapeutics Launches CAR T Trial for Lupus Nephritis](https://theregenreport.com/2026/09/10/fate-therapeutics-launches-car-t-trial-for-lupus-nephritis/) - The Phase 2 study will enroll about 53 patients to evaluate a single off-the-shelf CAR T-cell dose, with complete renal response at Week 26 as the primary endpoint. - The Regen Report
- [Consano Bio's Platelet-Derived Biologic May Ease Chronic Sciatica, New Study, Advancing RCT](https://theregenreport.com/2026/09/14/consano-bios-platelet-derived-biologic-may-ease-chronic-sciatica-new-study-advancing-rct/) - Nonclinical findings showed the investigational therapy reduced inflammation, tissue damage and pain sensitivity while promoting cellular repair, supporting its ongoing Phase 1 trial. - The Regen Report
- [FDA Clears Colorado University Anschutz' CAR T-Cell Trial for Colorectal Cancer](https://theregenreport.com/2026/09/11/fda-clears-colorado-university-anschutz-car-t-cell-trial-for-colorectal-cancer/) - The investigators will evaluate a dual-target CAR T-cell therapy designed to attack B7-H3 and IL-8 in adults and children with advanced solid tumors. - The Regen Report
- [Longeveron and Miller School Stem Cell Research Advances to Finals of XPRIZE Healthspan for Aging Frailty](https://theregenreport.com/2026/09/14/longeveron-and-miller-school-stem-cell-research-advances-to-finals-of-xprize-healthspan-for-aging-frailty/) - Longeveron received a $1 million milestone award to test laromestrocel’s potential to reduce aging frailty and improve muscle, cognitive and immune function in older adults. - The Regen Report
- [Humacyte's Vascular Tissue Graft Nabs FDA Authorization for 36-Month Shelf Life](https://theregenreport.com/2026/09/14/humacytes-vascular-tissue-graft-nabs-fda-authorization-for-36-month-shelf-life/) - Additional stability data showed the bioengineered vessel maintains quality specifications for three years under approved refrigeration, giving hospitals greater inventory flexibility for urgent vascular repairs. - The Regen Report
- [Webinar: Reimagining Gene-Modified T Cell Manufacturing - New Data on Integrating Isolation, Activation, Transduction, and Expansion in a Single Quantum Flex™ Workflow](https://theregenreport.com/2026/08/11/webinar-reimagining-gene-modified-t-cell-manufacturing-new-data-on-integrating-isolation-activation-transduction-and-expansion-in-a-single-quantum-flex-workflow/) - Discover new data showcasing a streamlined approach to gene-modified T cell manufacturing that brings together multiple critical unit operations into a single, integrated workflow. - The Regen Report
- [iPSC-Derived Heart Cells Show Early Promise in Chinese Heart Failure Trial](https://theregenreport.com/2026/08/25/ipsc-derived-heart-cells-show-early-promise-in-chinese-heart-failure-trial/) - HELP Therapeutics’ iPSC-derived cardiomyocytes improved walking distance, myocardial perfusion and heart wall thickening when added to bypass surgery in a 20-patient randomized trial. - The Regen Report
- [Kangstem Biotech's Stem Cell for Knee Osteoarthritis Phase 2a Reports Significant Results](https://theregenreport.com/2026/08/25/kangstem-biotechs-stem-cell-for-knee-osteoarthritis-phase-2a-reports-significant-results/) - The Korean biotech company reported improved pain, joint function, and MRI-based structural measures versus placebo at 24 weeks, with no drug-related serious adverse events. - The Regen Report
- [Webinar: Inside eXmoor’s Cell & Gene GMP Facility, Designed for Uncertainty](https://theregenreport.com/2026/08/01/webinar-inside-exmoors-cell-gene-gmp-facility-designed-for-uncertainty/) - eXmoor Pharma's experts will present a case study of capabilities and lessons learned scaling its 65,000 foot GMP cell and gene therapy manufacturing center in the UK. - The Regen Report
- [Guts & Glory: Both of Cynata’s iPSC Trials Flop, GVH Phase 2 and KOA Phase 3](https://theregenreport.com/2026/07/05/guts-glory-both-of-cynatas-ipsc-trials-flop-gvh-phase-2-and-koa-phase-3/) - Sad day for the industry, here's a summary of the CEO/Executive Chairman's readouts of the trials. - The Regen Report
- [Aspen Neuroscience Nabs FDA RMAT Designation for its Parkinson's Cell Therapy](https://theregenreport.com/2026/08/02/aspen-neuroscience-nabs-fda-rmat-designation-for-its-parkinsons-cell-therapy/) - The designation gives Aspen added FDA support as it advances sasineprocel, a personalized autologous cell therapy for Parkinson’s disease, through clinical development. - The Regen Report
- [Life Biosciences Doses First Patient in Phase 1 of ER‑100 for Optic Neuropathies, Aiming to Rejuvenate Aging Cells](https://theregenreport.com/2026/08/01/life-biosciences-doses-first-patient-in-phase-1-of-er-100-for-optic-neuropathies-aiming-to-rejuvenate-aging-cells/) - The trial will assess the safety and tolerability of ER‑100, an epigenetic restoration therapy designed to restore retinal ganglion cell function, while also measuring visual outcomes. - The Regen Report
- [CREATE Medicines to Launch First Phase 1/2 In Vivo Trial of CAR-T Candidate CRT-402 for Autoimmune Diseases in Australia](https://theregenreport.com/2026/08/01/create-medicines-to-launch-first-phase-1-2-in-vivo-trial-of-car-t-candidate-crt-402-for-autoimmune-diseases-in-australia/) - The approval enables CREATE to start enrolling Australian patients with lupus, systemic sclerosis, and inflammatory myopathies in a first-in-human study of its in vivo CD19-targeted CAR-T therapy, designed to deplete harmful B cells without the complex manufacturing of traditional cell therapies. - The Regen Report
- [Novo Nordisk Publishes Results from Embryonic Stem Cell-Derived Dopaminergic Cells for Parkinson's Phase 1/2](https://theregenreport.com/2026/07/21/novo-nordisk-publishes-results-from-embryonic-stem-cell-derived-dopaminergic-cells-for-parkinsons-phase-1-2/) - The early trial, published in Nature, found that transplanting stem cell-derived dopaminergic progenitor cells into the brains of people with moderate Parkinson’s disease appeared feasible and showed a favorable 12-month safety profile, with the main risks tied to immunosuppression rather than the cell therapy itself. Importantly, they found no signs of tumors at 12 months. - The Regen Report
- [Kolon’s Cell-Based Gene Therapy Fails Phase 3 Osteoarthritis Trial](https://theregenreport.com/2026/07/21/kolons-cell-based-gene-therapy-fails-phase-3-osteoarthritis-trial/) - Kolon TissueGene’s phase 3 trial found its osteoarthritis therapy did not improve knee pain or function versus placebo, leaving the biotech to await results from a second late-stage study before deciding the program’s future. - The Regen Report
- [Sonoma Biotherapeutics to Automate its Treg Cell Manufacturing Using Cellares' Cell Shuttle Platform](https://theregenreport.com/2026/07/21/sonoma-biotherapeutics-to-automate-its-treg-cell-manufacturing-using-cellares-cell-shuttle-platform/) - The partnership will move Sonoma Biotherapeutics’ Phase 1 autologous CAR-Treg therapy for treatment-resistant rheumatoid arthritis onto Cellares’ automated manufacturing and quality control systems to improve scalability, consistency, and readiness for later-stage development. - The Regen Report
- [MEDIPOST Doses First US Patient in Umbilical Cord Stem Cell Therapy for Knee Osteoarthritis Phase 3](https://theregenreport.com/2026/07/12/medipost-doses-first-us-patient-in-umbilical-cord-stem-cell-therapy-for-knee-osteoarthritis-phase-3/) - And it begins... the Korean biotech company whose product, Cartistem, has been approved in Korea since 2012, passed Phase 3 in Japan, and is now entering the West. - The Regen Report
- [Replacing Magnetic Separation with Buoyancy: A Closer Look at Bracco's New Cell Selection Platform, BubbleGen™](https://theregenreport.com/2026/07/04/replacing-magnetic-separation-with-buoyancy-a-closer-look-at-braccos-new-cell-selection-platform-bubblegentm/) - Could a gentler, more scalable method improve how cells are isolated for advanced therapies? We spoke with Bracco’s Sophie He about the early data, manufacturing potential, and challenges ahead. - The Regen Report
- [Kenai Therapeutics Completes Enrollment of Phase 1b/2a Parkinson's iPSC Trial](https://theregenreport.com/2026/07/12/kenai-therapeutics-completes-enrollment-of-phase-1b-2a-parkinsons-ipsc-trial/) - The iPSC-derived neural cell therapy takes its next step in potentially restoring dopaminergic neurons lost to the condition. - The Regen Report
- [Cell Therapies to Manufacture CAR-T Therapy for Phase 1/2b Solid Tumor Trial in Australia](https://theregenreport.com/2026/07/12/cell-therapies-to-manufacture-car-t-therapy-for-phase-1-2b-solid-tumor-trial-in-australia/) - The Australian CDMO will manufacture A-SEEDS' therapy for the upcoming trial down under. - The Regen Report
- [FDA Selects Seven Participants for PreCheck Pilot Program to Advance US Drug Manufacturing](https://theregenreport.com/2026/06/30/fda-selects-seven-participants-for-precheck-pilot-program-to-advance-us-drug-manufacturing/) - The program is intended to accelerate US drug manufacturing scale-ups and address unmet patient needs. Two companies familiar to our regenerative readers, Cellares and Fujifilm Biotechnologies, made the list! - The Regen Report
- [Orca Bio Nabs FDA Approval of TREGZI, its Cell Therapy for Allogeneic Transplant in Adults with Blood Disorders](https://theregenreport.com/2026/06/30/orca-bio-nabs-fda-approval-of-tregzi-its-cell-therapy-for-allogeneic-transplant-in-adults-with-blood-disorders/) - Following Phase 3, TREGZI, known as Orca-T, had higher graft-versus-host disease-free survival at one year in patients receiving conventional blood stem cell transplants. - The Regen Report
- [Aspen Neuroscience Completes Cohort 3 and 4 Dosing in iPSC-Derived Phase 1/2a for Parkinson’s](https://theregenreport.com/2026/06/30/aspen-neuroscience-completes-cohort-3-and-4-dosing-in-ipsc-derived-phase-1-2a-for-parkinsons/) - The ASPIRO trial of sasineprocel is progressing; fifteen patients have been dosed with the commercial-ready formulation of the autologous cell therapy. - The Regen Report
- [Heartseed Doses First Patient in Historic iPSC-Derived Cardiomyocyte Trial Via Catheter](https://theregenreport.com/2026/06/27/heartseed-doses-first-patient-in-historic-ipsc-derived-cardiomyocyte-trial-via-catheter/) - The company's lead program, HS-001, required open heart surgery, while the new innovation allows for a much simpler, less invasive administration. - The Regen Report
- [Verismo Therapeutics to Use Cryoport's IntegriCell® Cryopreservation Services in its Clinical KIR-CAR T Cell Therapy Programs](https://theregenreport.com/2026/06/27/verismo-therapeutics-to-use-cryoports-integricell-cryopreservation-services-in-its-clinical-kir-car-t-cell-therapy-programs/) - Verismo is ramping up its 2 Phase 1s targeting solid tumors and B-Cell non-Hodgkin lymphomas, selecting Cryoport for its cold chain. - The Regen Report
- [CIRM Approves $662M Regen Med Funding, Largest in its History](https://theregenreport.com/2026/06/27/cirm-approves-662m-regen-med-funding-largest-in-its-history/) - The California agency is hoping to accelerate the cell & gene therapy industry amid uncertainty about federal funding. - The Regen Report
- [UniXell Biotechnology Nabs IND Clearance for its iPSC Parkinsons Therapy, UX-DA003](https://theregenreport.com/2026/06/25/unixell-biotechnology-nabs-ind-clearance-for-its-ipsc-parkinsons-thearpy-ux-da003/) - The Chinese company also received an IND in China a few weeks ago. Supported by good preclinical data, they'll advance clinical trials in both countries soon. - The Regen Report
- [First Patient Dosed in Neural Stem Cell Therapy for Huntington's Trial at UCI Health](https://theregenreport.com/2026/06/24/first-patient-dosed-in-neural-stem-cell-therapy-for-huntingtons-trial-at-uci-health/) - The embryonic-derived cell therapy is implanted directly into the brain, and this early trial hopes to establish safety and baseline efficacy. - The Regen Report
- [China Launches Huge Umbilical Stem Cell Longevity RCT](https://theregenreport.com/2026/06/23/china-launches-huge-umbilical-stem-cell-longevity-rct/) - PLA General Hospital has begun recruiting 2,000 adults aged 50 and older for a multicenter randomized trial to assess whether an approved umbilical cord mesenchymal stem cell therapy can safely improve aging-related decline. - The Regen Report
- [Hope Biosciences Publishes Positive Results from Stem Cells for TBI Study](https://theregenreport.com/2026/06/23/hope-biosciences-publishes-positive-results-from-stem-cells-for-tbi-study/) - The published Phase I/IIa study found that MSC therapy reduced markers of brain inflammation and improved depression, fatigue, pain, and imaging biomarkers in adults with chronic traumatic brain injury, supporting ongoing larger controlled trials. - The Regen Report
- [Steminent Filing for Japanese Approval of its Mesenchymal Stem Cell Therapy for Spinocerebellar Ataxia](https://theregenreport.com/2026/06/25/steminent-filing-for-japanese-approval-of-its-mesenchymal-stem-cell-therapy-for-spinocerebellar-ataxia/) - The company is hoping to be the 2nd Taiwanese cell therapy approved abroad. - The Regen Report
- [Inside Japan’s Regenerative Medicine Laws: JSRM Explains](https://theregenreport.com/2025/10/17/inside-japans-regenerative-medicine-laws-jsrm-explains/) - What can the world learn from Japan’s regenerative medicine laws? We sat down with the non-profit that helped design them to find out. - The Regen Report
- [CARsgen Nabs Chinese Approval of Satri-cel, its CAR-T Therapy for Stomach Cancer](https://theregenreport.com/2026/06/23/carsgen-nabs-chinese-approval-of-satri-cel-its-car-t-therapy-for-stomach-cancer/) - Based on the RCT results published in The Lancet, the Chinese biotech company has received approval for the world's first CAR-T for solid tumors. - The Regen Report
- [REPROCELL Receives Commercialization Award from Maryland Stem Cell Research Fund to Advance Universal, Hypoimmune iPSC Platforms](https://theregenreport.com/2026/06/22/reprocell-receives-commercialization-award-from-maryland-stem-cell-research-fund-to-advance-universal-hypoimmune-ipsc-platforms/) - The award will fund REPROCELL’s development of clinical-grade lines and a modular gene insertion platform designed to improve scalability, regulatory readiness, and access to off-the-shelf cell therapies. - The Regen Report
- [FDA Unveils its Plan for Operation TrialBlazer, Hoping to Streamline Drug Development Timelines](https://theregenreport.com/2026/06/22/fda-unveils-its-plan-for-operation-trialblazer-hoping-to-streamline-drug-development-timelines/) - The FDA outlined a broad set of new pilot programs, guidance updates, and support resources to streamline drug development from first-in-human studies through pivotal trials while reducing unnecessary regulatory burden and improving trial efficiency. - The Regen Report
- [FDA Reverses Decision on Regenxbio's Gene Therapy for Hunter's Syndrome, Supporting BLA Resubmission for Accelerated Approval](https://theregenreport.com/2026/06/22/fda-reverses-decision-on-regenxbios-gene-therapy-for-hunters-syndrome-supporting-bla-resubmission-for-accelerated-approval/) - REGENXBIO said the FDA will consider existing longer-term data for NAVSUNLI under the accelerated approval pathway without requiring new studies, allowing the company to target a BLA resubmission in Q3 2026. - The Regen Report
- [Hopstem Bio Nabs Phase 2 Approval for its iPSC-Derived Neural Cell Therapy for Chronic Ischemic Stroke](https://theregenreport.com/2026/06/21/hopstem-bio-nabs-phase-2-approval-for-its-ipsc-derived-neural-cell-therapy-for-chronic-ischemic-stroke/) - Their Chinese Phase 1 reportedly showed motor improvement in 90% of patients. With that data in hand, the FDA is allowing them to move forward out West. - The Regen Report
- [Georgia Joins Utah, Florida, and Other States in "Legalizing" Birth Tissue-Derived Stem Cell Therapies](https://theregenreport.com/2026/06/21/georgia-joins-utah-florida-and-other-states-in-legalizing-birth-tissue-derived-stem-cell-therapies/) - Georgia’s House Bill 1275 allows physicians and others to provide non-FDA-approved stem cell therapies derived from ethically sourced birth tissues, while imposing facility standards, disclosure rules, and patient consent requirements. - The Regen Report
- [TriCelX Nabs FDA Clearance for Phase 1/2 of First-in-Indication Cell Therapy Trial for CTE](https://theregenreport.com/2026/06/21/tricelx-nabs-fda-clearance-for-phase-1-2-of-first-in-indication-cell-therapy-trial-for-cte/) - Developed in hand with the DoD, the company is hoping to lay the groundwork for cell therapy in concussive injuries for soldiers, athletes, and the broader population. - The Regen Report
- [iPSC Race Heating Up: Cynata To Report Phase 3 iPSC-Derived Mesenchymal Stem Cell for Knee Osteoarthritis Soon](https://theregenreport.com/2026/05/27/ipsc-race-heating-up-cynata-to-report-phase-3-ipsc-derived-mesenchymal-stem-cell-for-knee-osteoarthritis-soon/) - Building on work at the University of Wisconsin-Madison, the Australian biotech company expects to release data from its Phase 3 iPSC-derived MSC KOA & Phase 2 Graft-vs-Host-Disease trials in the coming months. - The Regen Report
- [ElpasBio Completes Patient Enrollment in Phase III Trial of AlloJoin for Knee Osteoarthritis](https://theregenreport.com/2026/06/10/elpasbio-completes-patient-enrollment-in-phase-iii-trial-of-allojoin-for-knee-osteoarthritis/) - This marks the first stem cell therapy for KOA to reach Phase III in China. The race is heating up... - The Regen Report
- [Made Scientific Selected to Manufacture Columbia University's NOVAKnee, a 3D Printed Knee Replacement Made of Stem Cells and Scaffolds](https://theregenreport.com/2026/06/10/made-scientific-selected-to-manufacture-columbia-universitys-novaknee-a-3d-printed-knee-replacement-made-of-stem-cells-and-scaffolds/) - The Living Knee project is hoping to replace traditional knee replacements, expected to begin Phase 1 trials around 2028. - The Regen Report
- [The Jackson Laboratory Nabs $1.8M Grant from The Michael J. Fox Foundation to Advance Induced Pluripotent Stem Cells for Parkinson’s](https://theregenreport.com/2026/06/11/the-jackson-laboratory-nabs-1-8m-grant-from-the-michael-j-fox-foundation-to-advance-induced-pluripotent-stem-cells-for-parkinsons/) - JAX will use the funding to study how a genetic variant affects the disease and potentially standardize and characterize human cell models for broader research. - The Regen Report
- [Syntax Bio and Mayo Clinic Partnering on Cell Therapy for Type 1 Diabetes](https://theregenreport.com/2026/06/11/syntax-bio-and-mayo-clinic-partnering-on-cell-therapy-for-type-1-diabetes/) - Syntax is bringing its Cellgorithm cell-therapy discovery platform to the table, while Mayo Clinic will provide expertise in pancreatic biology and functional testing for preclinical diabetes. - The Regen Report
- [Cynata gains EU endorsement for Graft-vs-Host iPSC Study Plans](https://theregenreport.com/2026/06/11/cynata-gains-eu-endorsement-for-graft-vs-host-ipsc-study-plans/) - The Australian biotech company is hoping to tackle aGvHD in Europe, which appears to have twice as many cases as the USA. - The Regen Report
- [Cellares Joins New American Industrial Alliance, Advancing U.S. Biopharmaceutical Manufacturing Independence](https://theregenreport.com/2026/06/10/cellares-joins-new-american-industrial-alliance-advancing-u-s-biopharmaceutical-manufacturing-independence/) - The automated CDMO is hoping to reduce America's reliance on foreign biomanufacturing for advanced therapies. - The Regen Report
- [Interview: From Zero to One, How Terumo’s Ecosystem Blueprint Is Helping Scale Cell Therapies in Asia](https://theregenreport.com/2026/06/02/interview-from-zero-to-one-how-terumos-ecosystem-blueprint-is-helping-scale-cell-therapies-in-asia/) - Cell and gene therapies are advancing quickly, but the systems needed to deliver them at scale are still lagging behind. Terumo’s new Ecosystem Blueprint aims to bridge that gap in Asia-Pacific by integrating workflows, equipment, and training into a coordinated model to move from isolated innovation to repeatable, real-world delivery. - The Regen Report
- [FUJIFILM Cellular Dynamics' New iPSC Manufacturing Facility in Wisconsin, Quadrupling iPSC Research and Services](https://theregenreport.com/2026/05/21/fujifilm-cellular-dynamics-new-ipsc-manufacturing-facility-in-wisconsin-quadrupling-ipsc-research-and-services/) - The site will also serve as the company's new headquarters, expanding its services in iPSC-based drug discovery, regenerative medicine, and cell therapy work. - The Regen Report
- [Altman-Backed Regenerative Medicine Startup, Retro Biosciences, Closes Funding Round at $1.8B Valuation](https://theregenreport.com/2026/05/23/altman-backed-regenerative-medicine-startup-retro-biosciences-closes-funding-round-at-1-8b-valuation/) - The company is working on iPSC-derived, AAV, and small molecule therapies for neurodegenerative, orthopedic, and blood-based disorders, with the help of OpenAI's models which seem to be accelerating life science research. - The Regen Report
- [China Medical University Hospital Develops IV Neural Stem Cell-Derived Exosome Spinal Cord Injury Candidate](https://theregenreport.com/2026/05/27/china-medical-university-hospital-develops-iv-neural-stem-cell-derived-exosome-spinal-cord-injury-candidate/) - Published in the Journal of Nanobiotechnology, the iPSC-derived therapy delivers BDNF mRNA to injured spinal tissue, improving motor recovery in preclinical studies. - The Regen Report
- [Made Scientific Integrating RoosterBio's Mesenchymal Stem Cell Therapy Tech Into Its CDMO Offerings](https://theregenreport.com/2026/05/23/made-scientific-integrating-roosterbios-mesenchymal-stem-cell-therapy-tech-into-its-cdmo-offerings/) - Made Scientific will use RoosterBio's off-the-shelf MSCs, MSC expansion media, EV collection media, and related bioprocess expertise into its GMP operations. - The Regen Report
- [Maryland Stem Cell Research Commission Announces $12.6M For Regenerative Medicine, Next Funding Cycle Taking Applications Now](https://theregenreport.com/2026/05/23/maryland-stem-cell-research-commission-announces-12-6m-for-regenerative-medicine-next-funding-cycle-taking-applications-now/) - The 38 projects include work in diabetes, cancer, Parkinson's disease, stroke, sickle cell disease, chronic pain, and cardiovascular, bone, blood, digestive, and neurological disorders - The Regen Report
- [FibroBiologics Studying Fibroblast Treatment for Hantavirus](https://theregenreport.com/2026/05/20/fibrobiologics-studying-fibroblast-treatment-for-hantavirus/) - The company is expanding its preclinical work on acute respiratory syndrome to investigate whether its fibroblasts may help with deadly lung inflammation, vascular leakage, and tissue damage. - The Regen Report
- [Sana Biotechnology and Mayo Clinic Partner Up on Type 1 Diabetes Stem Cell-Derived Therapy, Phase 1 Potentially This Year](https://theregenreport.com/2026/05/20/sana-biotechnology-and-mayo-clinic-partner-up-on-type-1-diabetes-stem-cell-derived-therapy-phase-1-potentially-this-year/) - The partnership hopes to speed up the scalable development of SC451 for type 1 diabetes by standardizing treatment protocols, improving clinical delivery and post-care, and preparing the therapy for broader use across care sites. - The Regen Report
- [BioStem Technologies Receives 5 Patents for Placental Allografts](https://theregenreport.com/2026/05/20/biostem-technologies-receives-5-patents-for-placental-allografts/) - The 4 US and 1 European patents cover the design and manufacturing of the company's placental therapies. The company is targeting various applications across orthopedics, urology, and wound care. - The Regen Report
- [Kangstem Publishes Promising Phase 1 Results for Cord-Blood Derived Stem Cell Therapy in Knee Osteoarthritis, Post-MRI Data Suggest Potential Cartilage Regeneration](https://theregenreport.com/2026/05/19/kangstem-publishes-promising-phase-1-results-for-cord-blood-derived-stem-cell-therapy-knee-osteoarthritis-post-mri-data-suggest-potential-cartilage-regeneration/) - The Korean biotech company published the multicenter Phase 1 results in Nature, with 24-week follow-up MRI data that look promising as they continue development. - The Regen Report
- [Specialised Therapeutics Nabs Australian Approval For Chronic Graft-Versus-Host Disease Therapy In Patients Receiving Blood Stem Cells](https://theregenreport.com/2026/05/19/specialised-therapeutics-nabs-australian-approval-for-chronic-graft-versus-host-disease-therapy-in-patients-receiving-blood-stem-cells/) - The therapy has been approved in the USA since 2024, and it'll soon be available down under as well, potentially reimbursed by Australia's pharma subsidy program. - The Regen Report
- [Cellenkos To Begin Phase 2 Cord Blood-Derived Treg Trial for Aplastic Anemia](https://theregenreport.com/2026/05/19/cellenkos-to-begin-phase-2-cord-blood-derived-treg-trial-for-aplastic-anemia/) - Following their successful Phase 1, they've received clearance to begin Phase 2, where they'll assess whether it can reduce transfusion needs by calming the immune attack on bone marrow. - The Regen Report
- [Catalent to Supply Cartherics With iPSC Line To Manufacture CAR-NK Cell Therapies In Expanded Agreement](https://theregenreport.com/2026/05/18/catalent-to-supply-cartherics-with-ipsc-line-to-manufacture-car-nk-cell-therapies-in-expanded-agreement/) - Cartherics is developing multiple immune cell therapies for women's health, including its lead candidate, CTH-401, a CAR-NK therapy targeting ovarian cancer. - The Regen Report
- [MEDIPOST Calls On Charles River Laboratories To Help Scale GMP-Compliant Stem Cell Therapy](https://theregenreport.com/2026/05/17/medipost-calls-on-charles-river-laboratories-to-help-scale-gmp-compliant-stem-cell-therapy/) - As MEDIPOST ventures abroad, Charles River will provide GMP-compliant biologics and cell therapy testing services to help advance the pipeline into new markets. - The Regen Report
- [Royal Biologics and Jellagen Bringing Jellyfish-Derived Collagen Type Zero to the US Regenerative Medicine Market](https://theregenreport.com/2026/05/17/royal-biologics-and-jellagen-bringing-jellyfish-derived-collagen-type-zero-to-the-us-regenerative-medicine-market/) - The companies are working to bring jellyfish-derived Collagen Type Zero to North America, aiming to advance wound care and regenerative medicine with a sustainable alternative to mammalian collagen. - The Regen Report
- [Dark Horse Consulting Group and KunTuo Team Up To Accelerate Cell & Gene Therapy Trials In China](https://theregenreport.com/2026/05/16/dark-horse-consulting-group-and-kuntuo-team-up-to-accelerate-cell-gene-therapy-trials-in-china/) - The partnership combines Dark Horse's regulatory and development consulting with KunTuo's on-the-ground clinical trial execution to help companies launch studies faster and generate data to support regulatory submissions. - The Regen Report
- [Cellular Intelligence, Backed by Zuckerberg, Acquires Novo Nordisk's Parkinson's Cell Therapy Tech](https://theregenreport.com/2026/05/12/cellular-intelligence-backed-by-zuckerberg-acquires-novo-nordisks-parkinsons-cell-therapy-tech/) - Cellular Intelligence will use its AI platform to speed the clinical development and scalable manufacturing of a Phase 1/2 stem cell-derived Parkinson’s therapy acquired from Novo Nordisk, which also took an equity stake in the company. - The Regen Report
- [MEDIPOST's Umbilical Cord Stem Cell Phase 3 For Knee Osteoarthritis Meets Primary Endpoints In Japan, Setting Up Commercialization](https://theregenreport.com/2026/05/16/mediposts-umbilical-cord-stem-cell-phase-3-for-knee-osteoarthritis-meets-primary-endpoints-in-japan-setting-up-commercialization/) - The trial demonstrated that Cartistem can both relieve symptoms and regenerate cartilage, and the company is advancing manufacturing readiness for its first overseas commercialization move. - The Regen Report
- [Cord for Life Completes Dosing of First Clinical Trial Using Cord Blood Stem Cells for Lower Back Pain](https://theregenreport.com/2026/05/16/cord-for-life-completes-dosing-of-first-clinical-trial-using-cord-blood-stem-cells-for-lower-back-pain/) - The Phase 1 cord blood-derived stem cell therapy for sacroiliac joint-related lower back pain showed an encouraging early safety profile and symptom improvement, supporting plans to begin Phase 2 later this year. - The Regen Report
- [First Lupus Patients Dosed With Cabaletta Bio’s Rese-Cel, Manufactured on Cellares' Automated Cell Shuttle Platform](https://theregenreport.com/2026/05/12/first-lupus-patients-dosed-with-cabaletta-bios-rese-cel-manufactured-on-cellares-automated-cell-shuttle-platform/) - Cellares said its automated Cell Shuttle platform successfully produced GMP-compliant rese-cel doses for Cabaletta Bio’s RESET trial, marking an early proof point that automation can help lower costs and scale autologous CAR T manufacturing for autoimmune diseases. - The Regen Report
- [Thermo Fisher Scientific Unveils an Integrated Platform to Advance Scalable Cell Therapy Manufacturing](https://theregenreport.com/2026/05/12/thermo-fisher-scientific-unveils-an-integrated-platform-to-advance-scalable-cell-therapy-manufacturing/) - The Gibco CTS DynaXS Single Use Bioreactor is designed to help cell therapy developers scale from process development to cGMP-ready clinical manufacturing with greater flexibility, process control, and support for diverse applications such as cancer and autoimmune treatments. - The Regen Report
- [Trailhead Biosystems Expands iPSC-Derived Cell Portfolio With TrailBio Endothelial Cells](https://theregenreport.com/2026/05/09/trailhead-biosystems-expands-ipsc-derived-cell-portfolio-with-trailbio-endothelial-cells/) - Trailhead Biosystems has launched a functionally validated, highly pure iPSC-derived endothelial cell product designed to give researchers a scalable, reproducible human vascular model for angiogenesis, inflammation, drug screening and toxicity studies. - The Regen Report
- [Latus Bio Nabs $97 Million to Continue Neurodegenerative Gene Therapy Pipeline](https://theregenreport.com/2026/05/09/latus-bio-nabs-97-million-to-continue-neurodegenerative-gene-therapy-pipeline/) - The funding will support Latus Bio’s lead gene therapy programs in Huntington’s and CLN2 disease while advancing its low-dose AAV delivery platform designed to make gene therapies safer, more scalable, and accessible to broader patient populations. - The Regen Report
- [Immatics Testing Cellular Origins' Automated Cell Therapy Manufacturing Platform for Immuno-Oncology Programs](https://theregenreport.com/2026/05/09/immatics-testing-cellular-origins-automated-cell-therapy-manufacturing-platform-for-immuno-oncology-programs/) - The company is evaluating whether Cellular Origins’ Constellation automation platform can be used in selected Immatics manufacturing steps to improve consistency, efficiency, and scalability for next-generation cancer cell therapies. - The Regen Report
- [Interview: siRNA-Loaded Stem Cell Exosomes, Inside NurExone Biologic's Spinal Cord Injury Candidate](https://theregenreport.com/2025/11/21/interview-sirna-loaded-stem-cell-exosomes-inside-nurexone-biologics-spinal-cord-injury-candidate/) - NurExone's SCI candidate showed 100% gait recovery in rat models, and they're gearing up for human trials hopefully in 2026. Enjoy the interview! - The Regen Report
- [Innovacell Seeks $92M in Tokyo IPO to Advance Stem Cell Therapy Development](https://theregenreport.com/2026/02/25/innovacell-seeks-92m-in-tokyo-ipo-to-advance-stem-cell-therapy-development/) - The company is developing autologous cell therapies for fecal and urinary incontinence tied to weakened sphincter muscles. - The Regen Report
- [Miracell Receives FDA 510(k) Clearance for SMART M-CELL PRP Concentration System and SMART M-CELL Bone Marrow Concentration System](https://theregenreport.com/2026/04/12/miracell-receives-fda-510k-clearance-for-smart-m-cell-prp-concentration-system-and-smart-m-cell-bone-marrow-concentration-system/) - Miracell has received FDA 510(k) clearance for its SMART M-CELL blood and bone marrow concentration systems and kits, an automated platform the company says uses patented separation technology to preserve cell viability while concentrating growth factors and stem cell-rich regenerative components for applications including orthopedics, wound healing, and regenerative medicine. - The Regen Report
- [Mesoblast's Phase 3 Stem Cell for Lower Back Pain Trial Achieves Patient Recruitment, Results Expected Mid-2027](https://theregenreport.com/2026/04/29/mesoblasts-phase-3-stem-cell-for-lower-back-pain-trial-achieves-patient-recruitment-results-expected-mid-2027/) - Mesoblast said its 300-patient placebo-controlled Phase 3 study of rexlemestrocel-L for chronic low back pain remains on track, with top-line data expected in mid-2027 to support a planned FDA filing for the non-opioid cell therapy. - The Regen Report
- [Colorado Boulder's Injection Shows Promise for Reversing Osteoarthritis, Advancing ARPA-H Project](https://theregenreport.com/2026/04/29/colorado-boulders-injection-shows-promise-for-reversing-osteoarthritis-advancing-arpa-h-project/) - Researchers in Colorado are advancing injectable and biomaterial-based therapies that, in animal studies, restored damaged cartilage and bone by triggering the body’s own repair processes, potentially offering a minimally invasive alternative to pain management or joint replacement. - The Regen Report
- [Phase II Finds Umbilical Cord Blood Transplant With Pooled Stem Cell Product Shows 96% Survival and No Graft-Versus-Host Disease in Leukemia Patients](https://theregenreport.com/2026/04/29/phase-ii-finds-umbilical-cord-blood-transplant-with-pooled-stem-cell-product-shows-96-survival-and-no-graft-versus-host-disease-in-leukemia-patients/) - A phase 2 trial found that adding a lab-expanded stem cell product made from multiple pooled cord blood donors to a single cord blood transplant may broaden access to transplants for leukemia and myelodysplastic syndrome patients by speeding early immune recovery while avoiding severe transplant complications. - The Regen Report
- [Novartis Receives Positive CHMP Opinion for its Gene Therapy, Itvisma, for Spinal Muscular Atrophy](https://theregenreport.com/2026/04/26/novartis-receives-positive-chmp-opinion-for-gene-therapy-itvisma-for-spinal-muscular-atrophy/) - The recommendation is backed by Phase III data showing that Novartis’ one-time gene therapy improved motor function in people aged two and older with SMA and could lessen reliance on ongoing chronic treatment. - The Regen Report
- [Regeneron Nabs Deal with White House, New Gene Therapy Will Be Free](https://theregenreport.com/2026/04/26/regeneron-nabs-deal-with-white-house-new-gene-therapy-will-be-free/) - Regeneron said it will reduce Medicaid and future U.S. drug prices in line with other developed countries, enable direct discounted purchases of Praluent through TrumpRx.gov, and continue investing in domestic R&D and manufacturing under its agreement with the U.S. government. - The Regen Report
- [Mesoblast Acquires Mayo Clinic's Chimeric Antigen Receptor (CAR) Platform to Enhance its Stem Cell Therapies](https://theregenreport.com/2026/04/26/mesoblast-acquires-mayo-clinics-chimeric-antigen-receptor-car-platform-to-enhance-its-stem-cell-therapies/) - Mesoblast has secured exclusive global rights to a CAR technology platform to engineer its MSC therapies for more precise targeting and greater potency in inflammatory and autoimmune diseases, including bowel disease and lupus nephritis. - The Regen Report
- [Q&A - Inside iDEM, Mytos’ Automated Cell Therapy Manufacturing Platform](https://theregenreport.com/2026/04/18/qa-inside-idem-mytos-automated-cell-therapy-manufacturing-platform/) - Pluripotent stem cell therapies are expensive, upwards of $500K–$1M per dose. Mytos has developed an automated manufacturing platform to bring that down, it's currently being used by many companies, including Aspen Neuroscience for its iPSC-derived Parkinson's Phase 3. We sat down with co-founders Ali and Ignacio to hear how it works and where the company/industry is headed. - The Regen Report
- [Interview: Veterinary Stem Cells - Gallant’s Quest for the First FDA-Approved MSC Therapy](https://theregenreport.com/2026/04/17/interview-veterinary-stem-cells-gallants-quest-for-the-first-fda-approved-msc-therapy/) - Gallant is betting the future of veterinary regenerative medicine lies in scalable, well-characterized cell therapies. By sourcing mesenchymal stem cells from uterine tissue collected during routine spays, it has built an off-the-shelf platform with consistent, high-yield cells and FDA-aligned manufacturing, with a potential first FDA approval on the horizon. - The Regen Report
- [TBMC Opens GMP Facility in Zhubei, Taiwan for Cell, Gene, and mRNA Manufacturing](https://theregenreport.com/2026/04/19/tbmc-opens-gmp-facility-in-zhubei-taiwan-for-cell-gene-and-mrna-manufacturing/) - This marks Taiwan’s first GMP facility with mRNA and nucleic acid manufacturing capabilities to expand its CRDMO services and support advanced therapies from development through commercial production. - The Regen Report
- [Orthocell Secures US Department of Defense Approval for Remplir Collagen Nerve Wrap](https://theregenreport.com/2026/04/18/orthocell-secures-us-department-of-defense-approval-for-remplir-nerve-repair/) - Orthocell has gained approval for its Remplir nerve repair device across U.S. Department of Defence and Veterans Affairs hospital networks, expanding access to more than 220 military and veteran care facilities as it uses its distributor network to drive adoption in trauma-focused surgical settings. - The Regen Report
- [Dark Horse Consulting Acquires Bruder Consulting, Launches New Regenerative Medicine Division](https://theregenreport.com/2026/01/11/dark-horse-consulting-acquires-bruder-consulting-launches-new-regenerative-medicine-division/) - The acquisition brings expanded expertise in regenerative medicine, tissue repair, and biomaterials to Dark Horse Consulting’s service portfolio. - The Regen Report
- [AAOS Launches New Orthobiologics Registry to Improve Knee Osteoarthritis Research](https://theregenreport.com/2026/02/03/aaos-launches-new-orthobiologics-registry-to-improve-knee-osteoarthritis-research/) - The new registry aims to address evidence gaps and track long-term outcomes for orthobiologic treatments. - The Regen Report
- [Gallant Reports Positive Pilot Data for Feline Osteoarthritis Stem Cell Therapy; Receives FDA Eligibility for Expanded Conditional Approval Pathway](https://theregenreport.com/2026/04/17/gallant-reports-positive-pilot-data-for-feline-osteoarthritis-stem-cell-therapy-receives-fda-eligibility-for-expanded-conditional-approval-pathway/) - Gallant said its pilot study found that intravenous stem cell therapy significantly improved pain and quality of life in cats with osteoarthritis versus placebo, supporting a faster regulatory route as the company pursues a disease-modifying treatment for an underserved condition. - The Regen Report
- [Bracco Upgrading its Cell Therapy Manufacturing Plant for 2027 Production](https://theregenreport.com/2026/04/17/bracco-upgrading-its-cell-therapy-manufacturing-plant-for-2027-production/) - The Geneva site upgrade will expand Bracco’s GMP production capacity for its microbubble-based cell selection and activation platform, aiming to simplify cell therapy manufacturing and support clinical availability by mid-2027. - The Regen Report
- [XellSmart Launches iPSC Phase II for Parkinson's Following Encouraging Phase I Results](https://theregenreport.com/2026/04/14/xellsmart-launches-ipsc-phase-ii-for-parkinsons-following-encouraging-phase-i-results/) - The Phase II study will test XellSmart’s iPSC-derived off-the-shelf cell therapy in 30 Parkinson’s patients after Phase I showed meaningful motor and quality-of-life gains with no transplant-related adverse events. - The Regen Report
- [Xintela Granted U.S. Patent for XSTEM Treatment of Difficult-to-Heal Wounds and Skin Defects](https://theregenreport.com/2026/04/14/xintela-granted-u-s-patent-for-xstem-treatment-of-difficult-to-heal-wounds-and-skin-defects/) - The patent strengthens Xintela’s U.S. protection for XSTEM as a regenerative treatment for chronic wounds and skin damage, supported by preclinical results showing improved healing and reduced scarring and by ongoing clinical development in hard-to-heal ulcers and burns. - The Regen Report
- [Scripps Health Receives $12.7 Million Grant for Stem Cell Knee Research](https://theregenreport.com/2026/04/13/scripps-health-receives-12-7-million-grant-for-stem-cell-knee-research/) - The San Diego non-profit has received a $12.7 million grant to advance scaffold-free tissue engineering research aimed at repairing knee cartilage and bone damage. - The Regen Report
- [NurExone Biologic’s U.S. Subsidiary Exo-Top and BioXtek Sign LOI to Partner On Exosome Manufacturing and Commercialization](https://theregenreport.com/2026/04/13/nurexone-biologics-u-s-subsidiary-exo-top-and-bioxtek-sign-loi-to-partner-on-exosome-manufacturing-and-commercialization/) - Exo-Top and BioXtek have signed a non-binding letter of intent to explore a partnership focused on GMP manufacturing, clinical supply, and potential commercialization of bone marrow-derived mesenchymal stem cell exosomes. - The Regen Report
- [Proposed Stem Cell Class Action: "QC Kinetix Illegally Fails to Disclose Lack of FDA Approval of ‘Worthless’ Stem Cell, Regenerative Treatments in Florida"](https://theregenreport.com/2026/04/12/proposed-stem-cell-class-action-lawsuit-qc-kinetix-illegally-fails-to-disclose-lack-of-fda-approval-of-worthless-stem-cell-regenerative-treatments-in-florida/) - A proposed class action alleges QC Kinetix and related defendants failed to disclose that certain regenerative pain treatments were not FDA-approved and used misleading financing offers to sell them. - The Regen Report
- [Korea Launches First Clinical-Grade iPSC Distribution for Research and Therapeutics Development](https://theregenreport.com/2026/04/12/korea-launches-first-clinical-grade-ipsc-distribution-for-research-and-therapeutics-development/) - South Korea’s KDCA has begun distributing the nation’s first clinical-grade induced pluripotent stem cell lines, a move expected to cut costs and speed development of artificial blood and other cell-based therapies. - The Regen Report
- [Medipost to Launch Phase 3 of CARTISTEM, its Cord Blood Stem Cell Therapy, for Knee Osteoarthritis](https://theregenreport.com/2026/02/06/medipost-to-launch-phase-3-of-cartistem-its-cord-blood-stem-cell-therapy-for-knee-osteoarthritis/) - Based on their results in Korea/Japan, they received a Phase 3 fast track in the USA, and hope to show true cartilage regeneration. Potentially historic moment for the industry coming. - The Regen Report
- [Bracco Enters Cell Therapy Manufacturing with Cell Selection and Activation Technologies](https://theregenreport.com/2026/02/06/bracco-enters-cell-therapy-manufacturing-with-cell-selection-and-activation-technologies/) - The lipid microbubble platform aims to enhance cell therapy manufacturing, adapted from its clinically validated ultrasound imaging tech. - The Regen Report
- [Arizona Pushes New Stem Cell Therapy Bill](https://theregenreport.com/2026/02/23/arizona-pushes-new-stem-cell-therapy-bill/) - Arizona lawmakers are advancing SB 1214, a bill that would allow certain non-FDA-approved stem cell and birth tissue therapies, with limitations. - The Regen Report
- [Longeveron Granted Chinese Patent for Potency Assay Methods for Assessing Human Mesenchymal Stem Cells](https://theregenreport.com/2026/04/11/longeveron-granted-chinese-patent-for-potency-assay-methods-for-assessing-human-mesenchymal-stem-cells/) - Longeveron has received a Chinese patent covering potency assay methods used to assess human mesenchymal stem cells from multiple tissue sources and induced pluripotent stem cells, extending the company’s patent rights in China through 2041. - The Regen Report
- [HexemBio Emerges from Stealth Mode with $10.4 Million Raised for Blood Stem Cell Rejuvenation Therapy Development](https://theregenreport.com/2026/04/12/hexembio-emerges-from-stealth-mode-with-10-4-million-raised-for-blood-stem-cell-rejuvenation-therapy-development/) - HexemBio plans to advance its platform designed to rejuvenate aging blood stem cells, with an initial focus on improving bone marrow transplant outcomes in blood cancers. - The Regen Report
- [Indiana University Opens New Stem Cell Research Center for Alzheimer's and Dementias](https://theregenreport.com/2025/10/03/indiana-university-opens-new-stem-cell-research-center-for-alzheimers-and-dementias/) - Indiana University’s new MAP-AD center will use stem-cell-derived brain models and AI to advance Alzheimer’s research and drug development. - The Regen Report
- [New Korean Stem Cell Hub Coming to Baltimore, Focused on OA and Alzheimer's Research](https://theregenreport.com/2025/11/22/new-korean-stem-cell-hub-coming-to-baltimore-focused-on-oa-and-alzheimers-research/) - Nature Cell’s new facility will focus on stem cell therapeutics, research, and manufacturing, supported by the Maryland Stem Cell Research Fund. - The Regen Report
- [New Startup iOrganBio Launches with $2M for AI-Based Cell Manufacturing Platform, CellForge™](https://theregenreport.com/2025/12/14/new-startup-iorganbio-launches-with-2m-for-ai-based-cell-manufacturing-platform-cellforge/) - The company’s AI-powered CellForge™ platform aims to streamline and scale the production of engineered human cells and organoids. - The Regen Report
- [Singapore's EUDA Launching Stem Cell Clinic in Shenzen, Upgrading Manufacturing Platform for iPSC and Immunotherapy](https://theregenreport.com/2025/12/31/singapores-euda-launches-new-stem-cell-therapy-clinic-in-shenzen-and-developing-ipsc-platform/) - The new clinic will offer stem cell therapies, AI-guided health management, and combine Eastern and Western medical approaches, along with developing new immunotherapies and iPSCs. - The Regen Report
- [Xtant Medical Launches New Synthetic Bone Graft, nanOss Strata, for Enhanced Healing](https://theregenreport.com/2026/01/02/xtant-medical-launches-new-synthetic-bone-graft-nanoss-strata-for-enhanced-healing/) - The new graft material is designed for improved integration with patients' tissues, and it's available through distributors now. - The Regen Report
- [Cellistic Unveils New Induced Pluripotent Stem Cell Manufacturing Platforms for Cancer and Regenerative Therapies](https://theregenreport.com/2026/01/22/cellistic-unveils-new-induced-pluripotent-stem-cell-manufacturing-platforms-for-cancer-and-regenerative-therapies/) - The new platforms aim to streamline large-scale production of iPSC-derived cell therapies for new indications. - The Regen Report
- [REPROCELL Launches StemEdit: AI-Designed Gene Editing System and iPSC Product Lines for Clinical Use](https://theregenreport.com/2026/02/02/reprocell-launches-stemedit-ai-designed-gene-editing-system-and-ipsc-product-lines-for-clinical-use/) - The new open source gene editing services are ready to help iPSC developers create off-the-shelf allogeneic cell therapies at scale. - The Regen Report
- [CellFiber Launches GMP-Compliant Extruder for Advanced Cell Therapy Manufacturing](https://theregenreport.com/2026/02/01/cellfiber-launches-gmp-compliant-cell-fiber-extruder-for-advanced-cell-therapy-manufacturing/) - The new CellFiber Extruder aims to address manufacturing bottlenecks in cell therapy by enabling scalable, GMP-compliant cell production. - The Regen Report
- [Johnson & Johnson Invests $1 Billion in Next-Gen Cell Therapy Manufacturing in Pennsylvania](https://theregenreport.com/2026/02/25/johnson-johnson-invests-1-billion-in-next-gen-cell-therapy-manufacturing-in-pennsylvania/) - This is part of J&J's $55B investment in US manufacturing over the next few years. - The Regen Report
- [New Neural Cell Therapy Company, Oryon Cell Therapies, Emerges Focused on Neurodegenerative Conditions](https://theregenreport.com/2026/03/26/new-neural-cell-therapy-company-oryon-cell-therapies-emerges-focused-on-neurodegenerative-conditions/) - The company has emerged from stealth mode with a new $21 million Series A tranche (bringing total funding to $42 million), appointed Ron Cohen, M.D. as CEO, and reported early Phase 1b/2a Parkinson’s neuron replacement therapy data showing motor improvements and neuroimaging evidence of restored dopaminergic signaling. - The Regen Report
- [Keck Medicine of USC Starting Parkinson's Stem Cell Therapy Trial](https://theregenreport.com/2026/02/25/keck-medicine-of-usc-starting-parkinsons-stem-cell-therapy-trial/) - Keck Medicine of USC is participating in a small Phase 1 clinical trial evaluating the safety and early effectiveness of implanting induced pluripotent stem cell-derived dopamine-producing cells into the brain for Parkinson’s disease. - The Regen Report
- [CIRM Approves $73 Million for Early-Stage Regenerative Medicine Research in California](https://theregenreport.com/2025/09/28/cirm-approves-73-million-for-early-stage-regenerative-medicine-research-in-california/) - The new grants will support diverse early-stage research projects, aiming to advance regenerative medicine tools and future therapies. - The Regen Report
- [Maryland Stem Cell Research Fund Awards $4.7 million for Stem Cell Research](https://theregenreport.com/2025/10/03/maryland-stem-cell-research-fund-awards-4-7-million-for-stem-cell-research/) - The latest funding round backs 11 Maryland-based projects focused on advancing therapies and growing regenerative medicine manufacturing. - The Regen Report
- [ScaleReady Awards Nearly $2 Million in Grants for Cell and Gene Therapy Production in California](https://theregenreport.com/2025/10/11/scaleready-awards-nearly-2-million-in-grants-for-cell-and-gene-therapy-production-in-california/) - Eight California research centers receive funding to expand cell and gene therapy manufacturing. - The Regen Report
- [Keensight Capital Takes Majority Ownership in Orthobiologics Firm Isto Biologics](https://theregenreport.com/2025/10/14/keensight-capital-takes-majority-ownership-in-orthobiologics-firm-isto-biologics/) - Keensight Capital’s investment aims to accelerate Isto Biologics’ growth and international expansion in the orthobiologics sector. - The Regen Report
- [REPROCELL Awarded Maryland Stem Cell Fund Grant for Manufacturing Development](https://theregenreport.com/2025/10/25/reprocell-awarded-maryland-stem-cell-fund-grant-for-manufacturing-development/) - The new grant will help expand REPROCELL’s stem cell manufacturing capabilities and support Maryland’s growing regenerative medicine sector. - The Regen Report
- [Aspen Neuroscience Secures $115 Million Funding for Parkinson's Stem Cell Therapy](https://theregenreport.com/2025/11/22/aspen-neuroscience-secures-115-million-funding-for-parkinsons-stem-cell-therapy/) - The new funding round will help advance their iPSC-derived dopaminergic neuronal precursor cell trials, manufacturing, and continued development of other iPSC therapies. - The Regen Report
- [Maryland Stem Cell Research Commission Opens FY26 Stem Cell Research Funding Cycle](https://theregenreport.com/2025/11/25/maryland-stem-cell-research-commission-opens-fy26-stem-cell-research-funding-cycle/) - They're currently looking for proposals advancing stem cell discoveries, clinical applications, and commercialization. - The Regen Report
- [Trailhead Biosystems Secures Additional $20 Million to Develop Induced Pluripotent Stem Cells (iPSCs)](https://theregenreport.com/2026/01/18/trailhead-biosystems-secures-additional-20-million-to-develop-induced-pluripotent-stem-cells-ipscs/) - The new funding will support Trailhead’s efforts to commercialize iPSC-derived human cells for research and drug discovery applications. - The Regen Report
- [ENCell Receives FDA Orphan Drug for DMD Stem Cell Therapy](https://theregenreport.com/2026/02/25/encell-receives-fda-orphan-drug-for-dmd-stem-cell-therapy/) - ENCell's umbilical cord-derived mesenchymal stem cell therapy candidate EN001 received FDA orphan drug designation for Duchenne muscular dystrophy, marking its second designation after Charcot-Marie-Tooth disease and positioning it as a potential platform therapy for rare neuromuscular diseases. - The Regen Report
- [Excellthera's Blood Stem Cell Therapy Nabs NUB Status 1 in Germany](https://theregenreport.com/2026/02/22/excelltheras-blood-stem-cell-therapy-nabs-nub-status-1-in-germany/) - Zemcelpro (dorocubicel) is designed to support blood and immune system recovery after myeloablative conditioning in patients with hematologic diseases. - The Regen Report
- [BioRestorative Completes Enrollment in Phase 2 Stem Cell Trial for Chronic Lumbar Disc Disease](https://theregenreport.com/2026/02/22/biorestorative-completes-enrollment-in-phase-2-stem-cell-trial-for-chronic-lumbar-disc-disease/) - They've completed enrollment of 99 patients across 15 U.S. sites in its Phase 2 trial evaluating BRTX-100, a mesenchymal stem cell therapy for chronic lumbar disc disease. - The Regen Report
- [FibroBiologics Files Patent for New Fibroblast-Derived Platform for Orthopedic Indications](https://theregenreport.com/2026/02/06/fibrobiologics-files-patent-for-new-fibroblast-derived-platform-for-orthopedic-indications/) - The company says its platform may fundamentally change how cartilage loss and degenerative joint disease is treated globally. - The Regen Report
- [Pluristyx and Solesis Release New 3D Stem Cell Transfection Kit to Improve Efficiency and Reduce Toxicity](https://theregenreport.com/2026/02/06/pluristyx-and-solesis-release-new-3d-stem-cell-transfection-kit-to-improve-efficiency-and-reduce-toxicity/) - A new kit aims to streamline 3D iPSC transfection, offering higher efficiency and lower cytotoxicity for researchers and developers. - The Regen Report
- [GWOXI Files FDA Drug Master File for Adipose-Derived Stem Cell Bank](https://theregenreport.com/2026/02/06/gwoxi-files-fda-drug-master-file-for-adipose-derived-stem-cell-bank/) - GwoXi’s FDA filing aims to support cell therapy and exosome developers with a standardized, traceable stem cell source. - The Regen Report
- [Multiply Labs Nabs Partnership with AstraZeneca to Explore Robotic Automation in Cell Therapy Production](https://theregenreport.com/2026/02/03/multiply-labs-nabs-partnership-with-astrazeneca-to-explore-robotic-automation-in-cell-therapy-production/) - The collaboration will assess whether robotic automation can help scale up cell therapy manufacturing while maintaining GMP standards. - The Regen Report
- [Cellares Teams Up with Stanford to Automate Gene-Edited Stem Cell Therapy Manufacturing](https://theregenreport.com/2026/02/03/cellares-teams-up-with-stanford-to-automate-gene-edited-stem-cell-therapy-manufacturing/) - The partnership aims to streamline production and quality testing of gene-edited hematopoietic stem cell therapies for HIV and rare diseases. - The Regen Report
- [NextCell Reports Positive 7-Year Data for its Stem Cell Candidate, ProTrans, for Type 1 Diabetes](https://theregenreport.com/2026/02/03/nextcell-reports-positive-7-year-data-for-its-stem-cell-candidate-protrans-for-type-1-diabetes/) - Long-term follow-up suggests ProTrans may help preserve insulin production, with results varying by dose. - The Regen Report
- [Lineage Cell Therapeutics Receives Gene-Edited Stem Cell Line for Immune System Compatibility Studies](https://theregenreport.com/2026/02/03/lineage-cell-therapeutics-receives-gene-edited-stem-cell-line-for-immune-system-compatibility-studies/) - Lineage will evaluate the new gene-edited iPSC line for immune compatibility and manufacturing potential before pursuing exclusive rights with Factor Bioscience. - The Regen Report
- [FDA Approves StemCyte's Expanded Access Cord Blood Therapy Program for Long COVID](https://theregenreport.com/2026/02/01/fda-approves-stemcytes-expanded-access-cord-blood-therapy-program-for-long-covid/) - Based on Phase IIa trial data where 85% of patients had resolution of chronic fatigue over 20% with placebo, the company will now offer its cord blood cell therapy outside of the Phase III soon. - The Regen Report
- [Cellino and Polyphron Teaming Up to Scale Personalized Tissue Manufacturing Derived from iPSCs](https://theregenreport.com/2026/02/02/cellino-and-polyphron-teaming-up-to-scale-personalized-tissue-manufacturing-derived-from-ipscs/) - Polyphron will use Cellino's induced pluripotent stem cells in its "autonomous tissue foundry" to reproducibly manufacture cell and tissue therapies at scale. - The Regen Report
- [Longeveron Nabs Patent for Stem Cell Testing Techniques in Japan](https://theregenreport.com/2026/02/02/longeveron-nab-patent-for-stem-cell-testing-techniques-in-japan/) - With the right secured for stem cell potency, Longeveron is continuing its path forward with clinical trials for several mesenchymal stem cell indications. - The Regen Report
- [Wyoming Unveils "Stem Cell Freedom Act" to Allow Certain Non-FDA-approved Stem Cell Therapies](https://theregenreport.com/2026/02/01/wyoming-unveils-stem-cell-freedom-act-to-allow-certain-non-fda-approved-stem-cell-therapies/) - The proposed legislation, if passed, will allow culture-expanded autologous mesenchymal stem cell therapies in the Cowboy State. - The Regen Report
- [Chinese Study Reports Intranasal Muse Stem Cells Show Potential for Parkinson’s Treatment](https://theregenreport.com/2026/01/29/chinese-study-reports-intranasal-muse-stem-cells-show-potential-for-parkinsons-treatment/) - Researchers report that intranasal Muse cells improved motor function and reduced neurodegeneration in a Parkinson’s mouse model. - The Regen Report
- [Japan Approves JTEC's Cartilage Cell Therapy for Knee Osteoarthritis, Now Covered by Insurance](https://theregenreport.com/2026/02/01/japan-approves-jtecs-cartilage-cell-therapy-for-knee-osteoarthritis-now-covered-by-insurance/) - The company's autologous cartilage repair product will now be reimbursed under national health insurance, WOMAC scores improved better than hyaluronic acid injections. - The Regen Report
- [Pluri Helping Placenta-Derived Collagen Company Scale Up Production in Europe](https://theregenreport.com/2026/01/24/pluri-helping-placenta-derived-collagen-company-scale-up-production-in-europe/) - Resbiomed, a placental collagen materials manufacturer, is working on scaling up production for what appears regenerative ophthalmology in Europe. - The Regen Report
- [Cyto-Facto to Manufacture Steminent's Stem Cell Therapy for Spinocerebellar Ataxia, Seeking Conditional Approval in Japan](https://theregenreport.com/2026/01/24/cyto-facto-to-manufacture-steminents-stem-cell-therapy-for-spinocerebellar-ataxia-treatment-seeking-conditional-approval-in-japan/) - Stemchymal's CDMO has been selected, while the company seeks conditional approval in both Japan and Taiwan following Phase II results. - The Regen Report
- [China's ElpasBio Chooses Fosun Kairos to Commercialize AlloJoin, it's Stem Cell Therapy for Knee Osteoarthritis](https://theregenreport.com/2026/01/18/chinas-elpasbio-chooses-fosun-kairos-to-commercialize-allojoin-its-stem-cell-therapy-for-knee-osteoarthritis/) - AlloJoin is the first KOA stem cell therapy to reach Phase III in China, and it's gearing up for production soon. - The Regen Report
- [Study Finds Bone Marrow-Derived Stem Cells No Better Than Placebo for Chronic Low Back Pain](https://theregenreport.com/2026/01/23/study-finds-bone-marrow-derived-stem-cells-no-better-than-placebo-for-chronic-low-back-pain/) - The trial found no significant difference in pain or function outcomes between bone marrow injections and sham procedures over 12 months, but also had important limitations. - The Regen Report
- [Aspect Biosystems Acquires Novo Nordisk's Diabetes Stem Cell Therapy Tech](https://theregenreport.com/2026/01/22/aspect-biosystems-acquires-novo-nordisks-diabetes-stem-cell-therapy-tech/) - After stepping back from stem cell therapies last year, Novo is passing the torch on diabetes cell therapies to Aspect Biosystems, who will continue to commercialize the tech. - The Regen Report
- [BlueRock Cell Therapeutics Receives FDA Orphan Drug for its Ocular Stem Cell Therapy, OpCT-001](https://theregenreport.com/2026/01/22/bluerock-cell-therapeutics-receives-fda-orphan-drug-for-its-ocular-stem-cell-therapy-opct-001/) - OpCT-001 is an iPSC-derived cell therapy for retinitis pigmentosa, and it's now entering clinical testing following Orphan Drug status. - The Regen Report
- [Thermo Fisher and NVIDIA Partnering on AI-Driven Lab Automation](https://theregenreport.com/2026/01/18/thermo-fisher-and-nvidia-partnering-on-ai-driven-lab-automation/) - The companies aim to streamline workflows by integrating AI-driven automation, data connectivity, and advanced scientific instruments. - The Regen Report
- [Mesoblast Gets Good FDA Feedback on its Stem Cell Therapy for Back Pain, Rexlemestrocel-L, Progressing Towards BLA](https://theregenreport.com/2026/01/18/mesoblast-gets-good-fda-feedback-on-its-stem-cell-therapy-for-back-pain-rexlemestrocel-l-progressing-towards-bla/) - FDA feedback suggests rexlemestrocel-L may reduce chronic back pain and opioid use, Phase 3 underway. - The Regen Report
- [Chinese Phase 1 Parkinson's Stem Cell Trial Reportedly Showing Promise](https://theregenreport.com/2026/01/18/chinese-phase-1-parkinsons-stem-cell-trial-reportedly-showing-promise/) - South China Morning Post says it spoke with the iPSC research team, who relayed that the brain stem cell implant is showing promise in Parkinson's. - The Regen Report
- [Axol Bioscience Secures $2.8M to Develop iPSC Models](https://theregenreport.com/2026/01/18/axol-bioscience-secures-2-8m-to-develop-ipsc-models/) - The latest funding round will support US expansion, new stem cell-derived disease models, and increased manufacturing at its Edinburgh site. - The Regen Report
- [MEDIPOST Files IND for Phase 3 of Umbilical Cord Blood Stem Cell Product, Cartistem, in USA for Knee Osteoarthritis](https://theregenreport.com/2026/01/08/medipost-files-ind-for-phase-3-of-umbilical-cord-blood-stem-cell-product-cartistem-in-usa-for-knee-osteoarthritis/) - Building on its momentum in the East, MEDIPOST received a Phase 2 waver, and is heading right for Phase 3 in the US this year. This is one to watch. - The Regen Report
- [Cytora Therapeutics Teams Up with Made Scientific and Zeo ScientifiX to Launch Stem Cell Therapy for Diabetic Foot Ulcers in the US](https://theregenreport.com/2026/01/07/cytora-therapeutics-teams-up-with-made-scientific-and-zeo-scientifix-to-launch-stem-cell-therapy-for-diabetic-foot-ulcers-in-the-us/) - The partnership will focus on bringing oral mucosal stem cell therapy for diabetic foot ulcers to Florida, with FDA trials planned. - The Regen Report
- [UC Irvine Awarded $12 Million for First Human Trial of Stem Cell Therapy in Huntington’s Disease](https://theregenreport.com/2025/12/14/uc-irvine-awarded-12-million-for-first-human-trial-of-stem-cell-therapy-in-huntingtons-disease/) - A pioneering UC Irvine study will assess the safety and potential benefits of embryo-derived neural stem cell therapy for Huntington’s disease. - The Regen Report
- [StimLabs Receives FDA Approval for First Umbilical Cord-Derived Wound Sheet, Theracor](https://theregenreport.com/2026/01/03/stimlabs-receives-fda-approval-for-first-umbilical-cord-derived-wound-sheet-theracor/) - FDA clearance of Theracor introduces a new sheet-form umbilical cord device, expanding options for advanced wound care management. - The Regen Report
- [BlueRock Therapeutics' Cell Therapy for Parkinson's Gains Special Designation in Japan](https://theregenreport.com/2025/12/31/bluerock-therapeutics-cell-therapy-for-parkinsons-gains-special-designation-in-japan/) - Japan’s SAKIGAKE designation may help accelerate development and review of the embryonic stem cell-derived therapy. - The Regen Report
- [Iowa Attorney General Wins $1 Million Judgement Against "Scam Stem Cell Treatment Company"](https://theregenreport.com/2025/12/31/iowa-attorney-general-wins-1-million-judgement-against-scam-stem-cell-treatment-company/) - A court ordered major penalties and reimbursements after deceptive stem cell treatments were marketed to Iowans, particularly older residents. - The Regen Report
- [Hope Biosciences Reports Positive Phase II Results for Parkinson’s Stem Cell Therapy](https://theregenreport.com/2025/12/31/hope-biosciences-reports-positive-phase-ii-results-for-parkinsons-stem-cell-therapy/) - The Phase II trial showed significant motor function improvements and safety for an allogeneic stem cell therapy in Parkinson’s disease. - The Regen Report
- [Celularity to License its Amniotic Biologics to Opthalmic Startup DefEYE](https://theregenreport.com/2025/12/14/celularity-to-license-its-amniotic-biologics-to-opthalmic-startup-defeye/) - Celularity and DefEYE’s agreement aims to accelerate the development and commercialization of advanced regenerative biologic solutions for ophthalmic care. - The Regen Report
- [Potential Retraction Coming on Pivotal Phase 3 Stem Cell Trial for Heart Failure](https://theregenreport.com/2025/11/17/potential-retraction-coming-on-pivotal-phase-3-stem-cell-trial-for-heart-failure/) - What appeared to be a potential stem cell breakthrough is slowly being torn apart by peer-reviewers, who found damning inconsistencies in the data. - The Regen Report
- [Longeveron Receives Patent for Stem Cell Therapy to Treat Age-Related Frailty](https://theregenreport.com/2025/11/17/longeveron-receives-patent-for-stem-cell-therapy-to-treat-age-related-frailty/) - Dr. Joshua Hare's Longeveron is working on MSC therapy for seniors with "inflammaging", securing a new method-of-use patent with the USPTO. - The Regen Report
- [FDA's New Regulatory Pathway May Forego RCTs for Ultra-Rare Conditions](https://theregenreport.com/2025/11/23/fdas-new-regulatory-pathway-may-forego-rcts-for-ultra-rare-conditions/) - Dr. Marty Makary and Dr. Vinay Prasad publish new article in New England Journal of Medicine, proposing a new pathway. Here are the details. - The Regen Report
- [UK Follows USA's Bid to End Animal Testing, £75 Million Plan for Alternative Research Methods](https://theregenreport.com/2025/11/22/uk-follows-usas-bid-to-end-animal-testing-75-million-plan-for-alternative-research-methods/) - Both countries have made similar announcements this year to favor more humane, and human-relevant methods for testing therapies, but the UK seems to lay out more specific plans and timelines. - The Regen Report
- [ISSCR and the Canadian Stem Cell Network Team Up on Regen Med Workforce Initiative](https://theregenreport.com/2025/11/07/isscr-and-the-canadian-stem-cell-network-team-up-on-regen-med-workforce-initiative/) - A new joint initiative seeks to address workforce needs and skills gaps in the rapidly evolving regenerative medicine sector. - The Regen Report
- [Mayo Clinic Develops Stem Cell Patch to Potentially Repair Heart Damage Without Surgery](https://theregenreport.com/2025/11/17/mayo-clinic-develops-stem-cell-patch-to-potentially-repair-heart-damage-without-surgery/) - Researchers are testing a minimally invasive stem cell patch that could reduce the need for transplants. - The Regen Report
- [Gallant's Veterinary Stem Cell Therapy Nabs Key Safety Requirement from FDA for Cats with Severe Oral Disease](https://theregenreport.com/2025/11/17/gallants-veterinary-stem-cell-therapy-nabs-key-safety-requirement-from-fda-for-cats-with-severe-oral-disease/) - Gallant is inching closer to making veterinary history, potentially launching the first off-the-shelf stem cell product in the field next year. - The Regen Report
- [QC Kinetix Revamps Brand and Operations, Improves Average Clinic Profitability by 22.51%](https://theregenreport.com/2025/10/01/qc-kinetix-revamps-brand-and-operations-improves-average-clinic-profitability-by-22-51/) - Following a year-long overhaul, QC Kinetix reports improved clinic performance and profitability as it restarts franchise expansion plans. - The Regen Report
- [Gallant Advances First Ready-to-Use Feline Stem Cell Therapy Toward FDA Approval](https://theregenreport.com/2025/10/01/gallant-advances-first-ready-to-use-feline-stem-cell-therapy-toward-fda-approval/) - The therapy is getting close to conditional approval for our feline friends. - The Regen Report
- [New Review: A Lot of Symptom Relief from Stem Cell Knee Injections May Be Due to Placebo-Type Effects](https://theregenreport.com/2025/10/25/new-review-finds-most-symptom-relief-from-stem-cell-knee-injections-may-be-due-to-placebo-type-effects/) - Is the cart before the horse on orthopedic stem cell therapy? - The Regen Report
- [Tel Aviv University to Implant Lab-Grown Spinal Cord in Human Trial, Derived from Stem Cells](https://theregenreport.com/2025/10/03/tel-aviv-university-to-implant-lab-grown-spinal-cord-in-human-trial-derived-from-stem-cells/) - Researchers have seen good success in animal studies, and are advancing to the first clinical trials in humans. What a time to be alive. - The Regen Report
- [WEBINAR - How to Bring Regenerative Therapies to Market: The Science, the FDA, and the Business Reality](https://theregenreport.com/2025/10/19/webinar-how-to-bring-regenerative-therapies-to-market-the-science-the-fda-and-the-business-reality/) - Learn from Dr. Bruder's decades of experience helping over 800 regenerative therapies get to the bedside. - The Regen Report
- [Jackson Laboratory Acquires New York Stem Cell Foundation to Boost Biomedical Research and Precision Medicine Development](https://theregenreport.com/2025/10/25/jackson-laboratory-acquires-new-york-stem-cell-foundation-to-boost-biomedical-research-and-precision-medicine-development/) - The combined resources aim to accelerate early-stage research, driven by iPSCs, robotics, and AI. - The Regen Report
- [PRP Increases Stem Cell Migration by Activating Key Proteins, Study Finds](https://theregenreport.com/2025/10/25/prp-increases-stem-cell-migration-by-activating-key-proteins-study-finds/) - Researchers are examining how platelet-rich plasma may help adipose-derived stem cells move more effectively to support muscle repair. - The Regen Report
- [South Korea to Ease Stem Cell Therapy Regulations to Improve Access and Speed up Approvals](https://theregenreport.com/2025/10/19/south-korea-to-ease-stem-cell-therapy-regulations-to-improve-access-and-speed-up-approvals/) - The government aims to broaden eligibility for stem cell treatments, speed up approvals, and address regulatory barriers in biotech. - The Regen Report
- [India to Tighten Stem Cell and Gene Therapy Regulations](https://theregenreport.com/2025/10/23/india-to-tighten-stem-cell-and-gene-therapy-regulations/) - As some countries move to deregulate regenerative medicine, others are looking to batten the hatches. Where the USA fits on that spectrum is anybody's guess right now. - The Regen Report
- [Supreme Court Declines Stem Cell Case, Upholds FDA Oversight](https://theregenreport.com/2025/10/19/supreme-court-declines-stem-cell-case-upholds-fda-oversight/) - Goldwater urged SCOTUS to reconsider the FDAs stance on stem cells, SCOTUS refuses to take it on. - The Regen Report
- [Made Scientific and Streamline Bio Partner to Advance AI-Powered Robotic Cell Therapy Manufacturing](https://theregenreport.com/2025/10/19/made-scientific-and-streamline-bio-partner-to-advance-ai-powered-robotic-cell-therapy-manufacturing/) - The collaboration aims to automate cell therapy production, addressing manufacturing complexity, cost, and product consistency using AI-driven robotics. - The Regen Report
- [RoosterBio Helping Secretome Therapeutics Scale Cardiac Cell Therapy Manufacturing](https://theregenreport.com/2025/10/11/roosterbio-helping-secretome-therapeutics-scale-up-cell-therapy-manufacturing-for-cardiac-cell-therapy/) - RoosterBio and Secretome advance scalable cell therapy manufacturing with a new 50L bioreactor process for STM-01 clinical trials. - The Regen Report
- [Celularity Reports Phase 2 Trial Results on Placenta-Derived Cell Therapy for Diabetic Foot Ulcers with Peripheral Artery Disease](https://theregenreport.com/2025/10/14/celularity-reports-phase-2-trial-results-on-placenta-derived-cell-therapy-for-diabetic-foot-ulcers-with-peripheral-artery-disease/) - The Phase 2 study showed good results for placenta-derived cell therapy for diabetic foot ulcers complicated by PAD. - The Regen Report
- [TheWell Bioscience Introduces VitroGel® NEURON, a Synthetic Hydrogel Enhancing Neuronal Cell Culture](https://theregenreport.com/2025/10/11/thewell-bioscience-introduces-vitrogel-neuron-a-synthetic-hydrogel-enhancing-neuronal-cell-culture/) - Designed for 2D and 3D cultures, this platform aims to offer greater consistency and scalability in neuronal research. - The Regen Report
- [Mytos Nabs Cell Manufacturing Deals with StemSight, Rinri Therapeutics, and Novadip](https://theregenreport.com/2025/10/11/mytos-nabs-cell-manufacturing-deals-with-stemsight-rinri-therapeutics-and-novadip/) - Mytos has developed an automated cell manufacturing platform to serve the cell therapy industry as it matures - The Regen Report
- [RION Partners with Lonza for Large-Scale Production of Stem Cell-Derived Exosome Therapies](https://theregenreport.com/2025/10/03/rion-partners-with-lonza-for-large-scale-production-of-stem-cell-derived-exosometherapies/) - The partnership will support clinical and future commercial supply of RION’s exosome therapies for tissue repair and regenerative medicine. - The Regen Report
- [MaxCyte Partners with Adicet Bio for Gene Therapy Development Using Electroporation Technology](https://theregenreport.com/2025/10/03/maxcyte-partners-with-adicet-bio-for-gene-therapy-development-using-electroporation-technology/) - The agreement gives Adicet access to MaxCyte’s technology for developing scalable, non-viral gene-edited cell therapies. - The Regen Report
- [Palm Beach Town Council Rejects New Regenerative Medicine Center](https://theregenreport.com/2025/10/03/palm-beach-town-council-rejects-new-regenerative-medicine-center/) - Citing concerns over ground-floor medical use, council members debated balancing healthcare access with ongoing retail revitalization in the area. - The Regen Report
- [DarwinCell Presents Mesenchymal Stem Cell ALS Therapy at American Neurological Association Meeting](https://theregenreport.com/2025/09/30/darwincell-presents-mesenchymal-stem-cell-als-therapy-at-american-neurological-association-meeting/) - The Chinese biotech company shared promising preclinical and early clinical results for its novel ALS therapy - The Regen Report
- [Aspen Neuroscience Begins Third Cohort in Parkinson's Disease Stem Cell Therapy Trial with Commercial Formulation](https://theregenreport.com/2025/09/30/aspen-neuroscience-begins-third-cohort-in-parkinsons-disease-stem-cell-therapy-trial-with-commercial-formulation/) - Aspen’s trial advances with a commercial-ready, patient-derived cell therapy aiming to improve Parkinson’s outcomes and streamline clinical delivery. - The Regen Report
- [Cell X Technologies and BioLamina Partner on induced pluripotent stem cell (iPSC) Standardization](https://theregenreport.com/2025/10/01/cell-x-technologies-and-biolamina-partner-on-induced-pluripotent-stem-cell-ipsc-standardization/) - The collaboration aims to streamline iPSC manufacturing by combining automation with standardized reagents for reproducible, scalable cell therapy processes. - The Regen Report
- [Klotho Neurosciences to Acquire Turn Biotechnologies Assets, Secures $300 Million Deal](https://theregenreport.com/2025/10/01/klotho-neurosciences-to-acquire-turn-biotechnologies-assets-secures-300-million-deal/) - Klotho Neurosciences expands into cellular reprogramming with a planned Turn Biotechnologies acquisition and significant pharma partnership. - The Regen Report
- [New Study: Exosome Therapy from Umbilical Cord Stem Cells Shows Early Promise for Osteoarthritis](https://theregenreport.com/2025/09/28/new-study-exosome-therapy-from-umbilical-cord-stem-cells-shows-early-promise-for-osteoarthritis/) - Researchers are testing whether exosomes from umbilical cord stem cells can safely reduce inflammation and support cartilage repair in osteoarthritis. - The Regen Report
- [Axol Bioscience Expands iPSC Library to Accelerate Ophthalmology Research](https://theregenreport.com/2025/09/28/axol-bioscience-expands-ipsc-library-to-accelerate-ophthalmology-research/) - Axol Bioscience’s updated iPSC library will hopefully provide researchers with diverse patient-derived cell lines and tools for advanced ophthalmology studies. - The Regen Report
- [NIH Launches First National Organoid Development Center to Minimize Use of Animal Testing](https://theregenreport.com/2025/09/28/nih-launches-first-national-organoid-development-center-to-minimize-use-of-animal-testing/) - The new SOM Center aims to standardize organoid research, advancing human-based models and reducing animal testing in biomedical science. - The Regen Report
- [BlueRock Therapeutics Begins Phase III Trial of Stem Cell Therapy for Parkinson’s Disease](https://theregenreport.com/2025/09/28/bluerock-therapeutics-begins-phase-iii-trial-of-stem-cell-therapy-for-parkinsons-disease/) - The exPDite-2 trial will evaluate the safety and effectiveness of donor-derived stem cell therapy in Parkinson’s disease patients. - The Regen Report
- [Orthocell's Collagen Nerve Wrap, Remplir, Now Available to Australian Urologists for Prostate Surgery Recovery](https://theregenreport.com/2025/09/28/orthocells-collagen-nerve-wrap-remplir-now-available-to-australian-urologists-for-prostate-surgery-recovery/) - Australian urologists can now access Remplir to support nerve protection and recovery during robotic prostate cancer surgeries. - The Regen Report
- [Pluristyx and Solesis Partner on Stem Cell Research and Organoid Development](https://theregenreport.com/2025/09/24/pluristyx-and-solesis-partner-on-stem-cell-research-and-organoid-development/) - The partnership aims to deliver standardized tools for stem cell and organoid research, addressing reproducibility and scalability challenges. - The Regen Report
- [RBI Launching Phase 2 Brain Stem Cell Injection Trial for Alzheimer's](https://theregenreport.com/2025/09/24/rbi-launching-phase-2-brain-stem-cell-injection-trial-for-alzheimers/) - The trial will inject autologous stem cells directly into the brain to bypass the blood-brain-barrier. - The Regen Report
- [Xintela's Knee Osteoarthritis Stem Cell Product Shows Safety and Positive Efficacy After Two Years](https://theregenreport.com/2025/09/24/xintelas-knee-osteoarthritis-stem-cell-product-shows-safety-and-positive-efficacy-after-two-years/) - Patients receiving XSTEM’s highest dose reported ongoing pain relief and joint improvement two years after a single treatment. - The Regen Report
- [Japan Government Panel Approves Research on Human Embryos Created from Stem Cells](https://theregenreport.com/2025/09/22/japan-government-panel-approves-research-on-human-embryos-created-from-stem-cells/) - Japanese officials move to update guidelines as researchers explore stem cell-derived human embryos for infertility and genetic studies. - The Regen Report
- [DoD-Funded Stem Cell Trial Expands to Phase II for Traumatic Brain Injury](https://theregenreport.com/2025/09/22/dod-funded-stem-cell-trial-expands-to-phase-ii-for-traumatic-brain-injury/) - A new clinical trial in Texas will evaluate stem cell therapy’s potential to improve outcomes for adults with chronic TBI. - The Regen Report
- [Gameto Secures $44M in Series C Funding to Advance Phase 3 Stem Cell Trial in Reproductive Care](https://theregenreport.com/2025/09/22/gameto-secures-44m-in-series-c-funding-to-advance-phase-3-stem-cell-trial-in-reproductive-care/) - Gameto’s latest funding will accelerate late-stage clinical trials and regulatory efforts for its stem cell-based fertility therapy. - The Regen Report
- [Kerecis Expands Fish-skin for Wound Care Lineup](https://theregenreport.com/2025/09/22/kerecis-expands-fish-skin-for-wound-care-lineup/) - The latest additions aim to support clinicians treating smaller wounds, enhancing flexibility and workflow in surgical wound care. - The Regen Report
- [Orthocell Reports 81% Success Rate in Nerve Repair Study With Remplir](https://theregenreport.com/2025/09/22/orthocell-reports-81-success-rate-in-nerve-repair-study-with-remplir/) - Interim study results highlight Remplir’s consistent safety and effectiveness in nerve repair, supporting further clinical and regulatory efforts. - The Regen Report
- [Cedars-Sinai Sending Stem Cells to Space to Study Heart and Brain Organoids](https://theregenreport.com/2025/09/15/cedars-sinai-sending-stem-cells-to-space-to-study-heart-and-brain-organoids/) - Cedars-Sinai researchers will examine how microgravity affects the growth and development of heart and brain organoids in orbit. - The Regen Report
- [Silk Based Nerve Repair Technology begins Trials](https://theregenreport.com/2025/09/15/silk-based-nerve-repair-technology-begins-trials/) - The first use of silk-based SilkAxons™ aims to address large peripheral nerve injuries where current treatments fall short. - The Regen Report
- [Winston-Salem Lab Offering Free Access to Test Bed to Support Regenerative Medicine Startups](https://theregenreport.com/2025/09/15/winston-salem-lab-offering-free-access-to-test-bed-to-support-regenerative-medicine-startups/) - Startups in regenerative medicine gain free lab access, advanced equipment, and support to accelerate product development and commercialization. - The Regen Report
- [GC Therapeutics' Reports Cell Programming Breakthrough, Enhancing Cell Therapy Manufacturing](https://theregenreport.com/2025/09/15/gc-therapeutics-reports-cell-programming-breakthrough-enhancing-cell-therapy-manufacturing/) - GC Therapeutics unveils data showing rapid, precise generation of human microglia-like cells, advancing scalable cell therapy production. - The Regen Report
- [Kyoto University Team Creates Jawbone Tissue from Human Stem Cells (iPSCs)](https://theregenreport.com/2025/09/15/kyoto-university-team-creates-jawbone-tissue-from-human-stem-cells-ipscs/) - Researchers generated 3D jawbone tissue from induced pluripotent stem cells - The Regen Report
- [NurExone Granted U.S. Patent for Exosome Manufacturing Process, Enhancing Supply Chain Capabilities](https://theregenreport.com/2025/09/09/nurexone-granted-u-s-patent-for-exosome-manufacturing-process-enhancing-supply-chain-capabilities/) - NurExone secures U.S. patent protection for its exosome production method, supporting scale-up and clinical supply chain readiness. - The Regen Report
- [Hope Biosciences Awarded FDA RMAT Designation for Multiple Sclerosis Stem Cell Therapy](https://theregenreport.com/2025/09/07/hope-biosciences-awarded-fda-rmat-designation-for-multiple-sclerosis-stem-cell-therapy/) - The FDA designation follows promising Phase II trial results for Hope Biosciences’ stem cell therapy in relapsing-remitting multiple sclerosis. - The Regen Report
- [Pluristyx and BioLamina Join Forces to Enhance Stem Cell Therapy Development](https://theregenreport.com/2025/09/07/pluristyx-and-biolamina-join-forces-to-enhance-stem-cell-therapy-development/) - The collaboration aims to streamline iPSC-based therapy development by integrating advanced cell engineering with specialized culture matrices. - The Regen Report
- [European Commission Approves Zemcelpro®: First Sole Cell Therapy for Blood Cancer Patients Lacking Suitable Donors](https://theregenreport.com/2025/09/07/european-commission-approves-zemcelpro-first-sole-cell-therapy-for-blood-cancer-patients-lacking-suitable-donors/) - Zemcelpro® offers a new stem cell transplant option for adults with blood cancers unable to find compatible donors in Europe. - The Regen Report
- [University of Auckland Leads Pioneering CRISPR Gene Therapy Trial for Muscular Dystrophy](https://theregenreport.com/2025/09/07/university-of-auckland-leads-pioneering-crispr-gene-therapy-trial-for-muscular-dystrophy/) - Researchers are testing a novel CRISPR-based therapy for FSHD, with participants monitored for safety and long-term outcomes. - The Regen Report
- [Regenerative Spinal Cord Therapy: Interview with Nurexone Biologic's CEO, Dr. Lior Shaltiel](https://theregenreport.com/2025/08/28/regenerative-spinal-cord-therapy-interview-with-nurexone-biologics-ceo-dr-lior-shaltiel/) - Nurexone Biologic has developed an exosome therapy for nerve repair, we interviewed the CEO, Dr. Lior Shaltiel here. Enjoy! - The Regen Report
- [NurExone's Exosomes Outperform Commercial Standard in Regenerative Study](https://theregenreport.com/2025/08/17/nurexones-exosomes-outperform-commercial-standard-in-regenerative-study/) - Independent analysis finds NurExone’s exosomes deliver enhanced regenerative signals, showing promise for nerve repair and tissue healing applications. - The Regen Report
- [FDA Grants Fast Track Status to Stem Cell-Viral Therapy for Advanced Cancers](https://theregenreport.com/2025/08/17/fda-grants-fast-track-status-to-stem-cell-viral-therapy-for-advanced-cancers/) - Calidi’s CLD-201, a novel stem cell-based oncolytic virus therapy, moves forward. - The Regen Report
- [Capricor Therapeutics Announces FDA Type A Meeting to Discuss Duchenne Muscular Dystrophy Treatment Path](https://theregenreport.com/2025/08/17/capricor-therapeutics-announces-fda-type-a-meeting-to-discuss-duchenne-muscular-dystrophy-treatment-path/) - Capricor Therapeutics is coordinating with the FDA on regulatory steps for its Duchenne therapy, with updates expected soon. - The Regen Report
- [BioTissue Nabs Vizient Contract to offer Amniotic Allograft Products in the USA](https://theregenreport.com/2025/08/17/biotissue-nabs-vizient-contract-to-offer-amniotic-allograft-products-in-the-usa/) - The new agreement enables Vizient members broader access to BioTissue’s amniotic membrane products for diverse clinical applications. - The Regen Report
- [Sumitomo Pharma Submits Application for Japanese Approval of Stem Cell Therapy to Enhance Motor Function in Parkinson’s Disease](https://theregenreport.com/2025/08/16/sumitomo-pharma-submits-application-for-japanese-approval-of-stem-cell-therapy-to-enhance-motor-function-in-parkinsons-disease/) - Sumitomo Pharma and RACTHERA seek approval for a novel iPS cell-based therapy targeting motor symptoms in advanced Parkinson’s. - The Regen Report
- [NASA's New Mission will Study Stem Cell Expansion in Space](https://theregenreport.com/2025/08/04/nasas-new-mission-will-study-stem-cell-expansion-in-space/) - The Crew-11 mission launched on Friday, where they will support studies in stem cell growth, organ tissue, bacteriophage therapy, and advanced computing. - The Regen Report
- [Trailhead Biosystems Launches New iPSC-Derived Neurons for Parkinson's Research](https://theregenreport.com/2025/07/31/trailhead-biosystems-launches-new-ipsc-derived-neurons-for-parkinsons-research/) - The iPSC-derived A9 dopaminergic neurons will hopefully offer researchers a human-based model for Parkinson’s disease studies. - The Regen Report
- [NeuroScientific Chooses Q-Gen for its StemSmart Cell Therapy Platform](https://theregenreport.com/2025/07/31/neuroscientific-chooses-q-gen-for-its-stemsmart-cell-therapy-platform/) - The Australian biotech company is preparing for trials and commercialization of its stem cell therapy platform for Crohn's disease, StemSmart. - The Regen Report
- [Stem Cell Pioneers: iPSC Discovery, Potential, and Manufacturing, Interview with Dr. Koji Tanabe](https://theregenreport.com/2025/07/29/stem-cell-pioneers-ipsc-discovery-potential-and-manufacturing-interview-with-dr-koji-tanabe/) - Dr. Koji Tanabe discusses IPS cell advancements, mass manufacturing, and their future in medicine. - The Regen Report
- [Stem cell exosomes for spinal cord injury: Preclinical study shows improved motor function and blood flow](https://theregenreport.com/2025/05/26/stem-cell-exosomes-for-spinal-cord-injury-preclinical-study-shows-improved-motor-function-and-blood-flow/) - NurExone Biologic's exosome product moves one step closer to clinical trials with their latest data, published in Cyotherapy. - The Regen Report
- [Stem Cell-Derived Extracellular Vesicles Show Promise for Respiratory Disease](https://theregenreport.com/2025/07/23/stem-cell-derived-extracellular-vesicles-show-promise-for-respiratory-disease/) - Researchers are exploring whether stem cell-derived extracellular vesicles could offer safer, targeted therapies for respiratory diseases, but technical hurdles remain. - The Regen Report
- [New Trial: Mesenchymal Stem Cell Exosomes for Preventing and Treating Organ Failure After Aortic Dissection Surgery](https://theregenreport.com/2025/07/27/new-trial-mesenchymal-stem-cell-exosomes-for-preventing-and-treating-organ-failure-after-aortic-dissection-surgery/) - Researchers in China are testing whether exosomes can help prevent or treat organ failure after aortic dissection surgery. - The Regen Report
- [Jagiellonian University Develops New Stem Cell Treatment for Osteoarthritis, Completes Phase 2 Trials](https://theregenreport.com/2025/07/27/jagiellonian-university-develops-new-stem-cell-treatment-for-osteoarthritis-completes-phase-2-trials/) - Jagiellonian University researchers advanced an adipose mesenchymal stem cell-based osteoarthritis therapy, showing promising pain reduction and improved joint function in trials. - The Regen Report
- [NeuroScientific Appoints Dr. Cathy Cole to Lead Stem Cell Therapy Development for Crohn’s Disease](https://theregenreport.com/2025/07/27/neuroscientific-appoints-dr-cathy-cole-to-lead-stem-cell-therapy-development-for-crohns-disease/) - NeuroScientific brings Dr. Cole onboard as it advances stem cell research and prepares for clinical trials. - The Regen Report
- [New Trial: Umbilical Cord Stem Cell-Derived Exosome Nasal Drops for Neurodegenerative Diseases](https://theregenreport.com/2025/07/27/new-trial-umbilical-cord-stem-cell-derived-exosome-nasal-drops-for-neurodegenerative-diseases/) - Researchers will test whether nasal drops containing stem cell-derived vesicles can safely benefit people with a range of neurodegenerative diseases. - The Regen Report
- [Vita Therapeutics and I Peace Join Forces to Deliver Gene-Edited Stem Cells for Muscular Dystrophy](https://theregenreport.com/2025/07/27/vita-therapeutics-and-i-peace-join-forces-to-deliver-gene-edited-stem-cells-for-muscular-dystrophy/) - The companies will collaborate to leverage gene editing and GMP iPSC manufacturing to hopefully deliver new therapies. - The Regen Report
- [Japan and Belgium Partner Up to Promote Regenerative Nanobiotech](https://theregenreport.com/2025/07/27/japan-and-belgium-partner-up-to-promote-regenerative-nanobiotech/) - The Japanese Society for Regenerative Medicine and imec will jointly pursue nanobiotechnology for regen med applications. - The Regen Report
- [Neuroprotective Effects of SIRT1 Gene Therapy Protects Stem Cell-Derived Retinal Ganglion Cells from Oxidative Stress](https://theregenreport.com/2025/07/23/neuroprotective-effects-of-sirt1-gene-therapy-protects-stem-cell-derived-retinal-ganglion-cells-from-oxidative-stress/) - Researchers are exploring whether SIRT1 gene therapy can protect human retinal cells from damage linked to optic neuropathies. - The Regen Report
- [Exosomes Show Promise in Supporting Bone Fracture Healing and Regeneration](https://theregenreport.com/2025/07/23/exosomes-show-promise-in-supporting-bone-fracture-healing-and-regeneration/) - Researchers explored how exosomes could boost bone healing and pave the way for new regenerative therapies. - The Regen Report
- [Hope Biosciences Launches Phase Ib/IIa Stem Cell Trial for Early Alzheimer's Disease](https://theregenreport.com/2025/07/23/hope-biosciences-launches-phase-ib-iia-stem-cell-trial-for-early-alzheimers-disease/) - Hope Biosciences will study whether stem cell therapy can reduce inflammation or slow Alzheimer’s progression in a new clinical trial. - The Regen Report
- [FDA Grants Orphan Drug Designation to KLTO-202 Gene Therapy for ALS Treatment](https://theregenreport.com/2025/07/23/fda-grants-orphan-drug-designation-to-klto-202-gene-therapy-for-als-treatment/) - Klotho Neurosciences’ gene therapy is advancing plans for ALS clinical trials next year. - The Regen Report
- [New Systematic Review Finds Fat Stem Cell Therapy Reduces Knee Pain by 44-62%](https://theregenreport.com/2025/07/14/adipose-stem-cell-therapy-shows-promise-for-knee-osteoarthritis-when-combined-with-arthroscopy-new-systematic-review-finds/) - A new systematic review published in the Journal of Orthopaedic Surgery and Research suggests that combining micro-fragmented adipose tissue (MFAT) injections with knee arthroscopy may provide meaningful pain relief and functional improvement in knee osteoarthritis (KOA) patients, a population without many options. Background: Regenerative Approaches Emerge for KOA Knee osteoarthritis is a prevalent degenerative joint - The Regen Report
- [New Trial: Umbilical Cord Mesenchymal Stem Cells for Lupus](https://theregenreport.com/2025/07/20/new-trial-umbilical-cord-mesenchymal-stem-cells-for-lupus/) - The trial will investigate whether umbilical cord stem cell therapy can calm the autoimmune condition. - The Regen Report
- [Stem Cell and Spinal Stimulation Trial for Chronic Spinal Cord Injury](https://theregenreport.com/2025/07/20/stem-cell-and-spinal-stimulation-trial-for-chronic-spinal-cord-injury/) - The study will test whether combining umbilical cord stem cells and spinal cord stimulation can safely help people with chronic spinal cord injury. - The Regen Report
- [NurExone reports enhanced scalability and clinical readiness for upcoming exosome-based clinical trials for neurological conditions](https://theregenreport.com/2025/06/18/nurexone-reports-enhanced-scalability-and-clinical-readiness-for-upcoming-exosome-based-clinical-trials-for-neurological-conditions/) - The Israeli regenerative medicine company is moving one step closer to clinical trials for serious neurological indications such as TBI, spinal cord injury, etc. - The Regen Report
- [New Trial: iPSC-Derived Exosome Therapy for Moyamoya Disease](https://theregenreport.com/2025/07/20/new-trial-ipsc-derived-exosome-therapy-for-moyamoya-disease/) - Researchers are testing whether exosomes from stem cells can enhance blood vessel repair for Moyamoya patients after surgery. - The Regen Report
- [Stem Cell Trial: Umbilical Cord MSCs to Prevent Lung Disease in Preterm Infants](https://theregenreport.com/2025/07/20/stem-cell-trial-umbilical-cord-mscs-to-prevent-lung-disease-in-preterm-infants/) - Researchers will test if umbilical cord stem cell infusions can safely reduce lung disease in extremely premature infants. - The Regen Report
- [Stem Cell Trial: BlueRock Launches Study of iPSC-Derived Photoreceptor Cell Therapy for Inherited Retinal Diseases](https://theregenreport.com/2025/07/20/stem-cell-trial-bluerock-launches-study-of-ipsc-derived-photoreceptor-cell-therapy-for-inherited-retinal-diseases/) - The trial will test whether lab-grown photoreceptor cells can be safely transplanted to help people with inherited vision loss. - The Regen Report
- [Stem Cell Trial: iPSCs for Repairing Airway Damage in COPD](https://theregenreport.com/2025/07/20/stem-cell-trial-ipscs-for-repairing-airway-damage-in-copd/) - The study will test whether induced pluripotent stem cells can help repair airway damage in people with COPD. - The Regen Report
- [Longeveron Licenses Stem Cells from the University of Miami for Heart Disease](https://theregenreport.com/2025/07/21/longeveron-licenses-stem-cells-from-the-university-of-miami-for-heart-disease/) - The technology aims to generate safer heart muscle cells for cardiovascular disease therapies and research. - The Regen Report
- [Celularity to Offer Placenta-Based Stem Cell Therapies in Florida Under New Law](https://theregenreport.com/2025/07/11/celularity-to-offer-stem-cell-therapies-in-florida-under-new-law/) - By partnering with Fountain Life, the companies are hoping to deliver new therapies to patients in the sunshine state. - The Regen Report
- [BioRestorative Therapies nabs FDA IND clearance for Phase 2 trial of its autologous cultured mesenchymal stem cell therapy, 'BRTX-100" for spine conditions](https://theregenreport.com/2025/02/28/biorestorative-nabs-fda-clearance-of-ind-for-phase-2-trial-of-brtx-100-in-chronic-cervical-discogenic-pain/) - BioRestorative Therapies, a regenerative medicine company focused on stem cell-based therapies, has announced that the FDA has cleared its Investigational New Drug (“IND”) application for BRTX-100, a novel cell-based therapeutic engineered to target areas of the body that have little blood flow, for the treatment of chronic cervical discogenic pain (“cCDP”). The problem? Chronic Cervical - The Regen Report
- [Study: Mass General successfully restores corneas with patients’ own stem cells](https://theregenreport.com/2025/03/05/study-mass-general-successfully-restores-corneas-with-patients-own-stem-cells/) - Link to the study on Nature The problem? Visual disturbances caused by a deficiency of limbal epithelial stem cells (LESCs) in one eye, known as unilateral limbal stem cell deficiency (USCD). It's seemingly difficult to gauge how common USCD is, but some sources say it affects about 1–5 per 10,000 people. (1) LESCs are specialized - The Regen Report
- [Hope Biosciences launches stem cell trial for children with arthritis (Juvenile Rheumatoid/Idiopathic Arthritis)](https://theregenreport.com/2025/03/06/hope-biosciences-launches-stem-cell-trial-for-juvenile-idiopathic-arthritis-a-k-a-juvenile-rheumatoid-arthritis/) - Hope Biosciences has reportedly received FDA authorization to conduct a pediatric clinical trial using their adipose(fat)-derived mesenchymal stem cells (HB-adMSCs) to assess their impact on juvenile idiopathic arthritis (JIA) in children aged 2 to 16. This trial aims to determine whether intravenous (IV) infusion of these stem cells can alleviate symptoms and enhance the quality - The Regen Report
- [Wharton's Jelly-Derived Mesenchymal Stem Cells Shows Promise for Traumatic Brain Injury: Results from Phase I Study (2024)](https://theregenreport.com/2025/04/05/whartons-jelly-derived-mesenchymal-stem-cells-for-traumatic-brain-injury-results-from-phase-i-study/) - Traumatic brain injury (TBI) occurs when trauma disrupts normal brain functions, potentially causing severe physical, cognitive, and emotional impairments. Researchers are exploring stem cells as a possible treatment because these cells might help prevent further brain deterioration and encourage the regeneration of damaged brain tissue. Specifically, Wharton's Jelly-derived mesenchymal stem cells (WJ-MSCs) have reportedly shown - The Regen Report
- [Wharton's Jelly Composition Analysis: Growth Factors, Cytokines, Hyaluronic Acid, and Extracellular Vesicles Support its Potential Role in Regenerative Medicine (2020 Study)](https://theregenreport.com/2025/04/05/composition-analysis-of-umbilical-cord-derived-whartons-jelly-high-concentrations-of-growth-factors-cytokines-hyaluronic-acid-and-extracellular-vesicles-support-its-potential-role-in-rege/) - The interest in stem cells is booming and it may become legal in the USA shortly... however, there's a lot of conflicting information about the products, both from the companies selling them and the companies competing against them. One thing that's claimed by competing companies is that Wharton's Jelly (the jelly in umbilical cords) has - The Regen Report
- [Trailhead Biosystems launches iPSCs for blood-brain barrier and neurological research](https://theregenreport.com/2025/06/01/trailhead-biosystems-launches-ipscs-for-blood-brain-barrier-and-neurological-research/) - Researchers may now have a new tool to unlock insights into blood-brain barrier regulation and neurological disease mechanisms. - The Regen Report
- [New Study: Intrathecal Umbilical Stem Cells + Transcutaneous Stimulation for Spinal Cord Injury](https://theregenreport.com/2025/05/22/new-study-intrathecal-whartons-jelly-transcutaneous-spinal-cord-stimulation-in-chronic-spinal-cord-injury-guttmann-neurorecovery/) - The neurorehabilitation hospital in Spain will investigate if allogeneic umbilical-derived stem cell therapy can help enhance recovery. - The Regen Report
- [Joseph Spine Institute Launches Adipose Stem Cell Spine Institute in Florida](https://theregenreport.com/2025/04/10/joseph-spine-institute-launches-adipose-stem-cell-spine-institute-in-florida/) - Joseph Spine Institute launches its Center for Regenerative Spine Medicine in Tampa, offering minimally invasive stem cell therapies for chronic spinal conditions. - The Regen Report
- [Cellino and Matricelf Partnering to Scale Stem Cells for Spinal Cord Injury](https://theregenreport.com/2025/04/09/cellino-and-matricelf-partnering-to-scale-stem-cells-for-spinal-cord-injury/) - Cellino has successfully manufactured and delivered patient-specific autologous induced pluripotent stem cell (iPSC) lines from four donors to Matricelf for spinal cord injury treatment. - The Regen Report
- [Xtant Medical Releases Growth Factor Product to Improve Orthopedic/Spine Surgery Outcomes](https://theregenreport.com/2025/06/29/xtant-medical-releases-growth-factor-product-to-improve-orthopedic-spine-surgery-outcomes/) - OsteoFactor Pro™ targets improved orthopedic healing through enhanced bone regeneration and versatile scaffold compatibility. - The Regen Report
- [FDA approves IV adipose stem cell trial for Crohn's disease, a Phase 2b from L2 Bio](https://theregenreport.com/2025/05/22/fda-approves-iv-adipose-stem-cell-trial-for-crohns-disease-a-phase-2b-from-l2-bio/) - What appears to be a small stem cell banking company is working on expanded adipose stem cell therapy for various autoimmune conditions. - The Regen Report
- [Off-the-shelf stem cells for heart failure: Trial reports positive results, independent board recommends moving forward with using BioCardia's CardiALLO](https://theregenreport.com/2025/04/22/off-the-shelf-stem-cells-for-heart-failure-trial-reports-positive-results-independent-board-recommends-moving-forward-with-using-biocardias-cardiallo/) - BioCardia plans to move forward with enrollment of up to 39 participants in the United States. - The Regen Report
- [Brain cancer stem cell trial begins recruitment: Calidi Biotherapeutics ships first batch to Northwestern University for the trial](https://theregenreport.com/2025/04/22/calidi-biotherapeutics-recruiting-for-neural-stem-cell-trial-for-high-grade-glioma-at-northwestern-university/) - The trial leverages Calidi’s innovative virotherapy platform, offering new hope for combating this aggressive form of brain cancer. - The Regen Report
- [L2 Bio looking for Principal Investigators for its Phase 2B adipose stem cell trial for Crohn's Disease](https://theregenreport.com/2025/06/18/l2-bio-looking-for-principal-investigators-for-its-phase-2b-adipose-stem-cell-trial-for-crohns-disease/) - The FDA has recently approved them for what appears to be an expanded adipose MSC trial, looking for GI experienced physicians. - The Regen Report
- [UniXell Biotechnology doses first Parkinson's patient with iPSCs, reports improvements](https://theregenreport.com/2025/06/18/unixell-biotechnology-doses-first-parkinsons-patient-with-ipscs-reports-improvements/) - The Chinese biotech company reports that the patient showed notable improvements in sleep quality and motor function, with no serious adverse events. - The Regen Report
- [BrainStorm's ALS stem cell treatment reports 90% survival over 5 years in expanded access program](https://theregenreport.com/2025/06/18/brainstorms-als-stem-cell-treatment-reports-90-survival-over-5-years-in-expanded-access-program/) - BrainStorm's NurOwn, its ALS candidate stem cell therapy, has shown significantly higher five-year survival rates compared to expectations in a small 10 participant program. - The Regen Report
- [Vertex Reports Promising Results from Stem Cell Trial for Type 1 Diabetes](https://theregenreport.com/2025/06/29/vertex-reports-promising-results-from-stem-cell-trial-for-type-1-diabetes/) - Vertex recently presented encouraging Phase 1/2 results for zimislecel, a stem cell-derived therapy showing sustained insulin production in type 1 diabetes patients. - The Regen Report
- [NextCell Pharma Completes Patient Dosing in Pediatric Diabetes Stem Cell Study](https://theregenreport.com/2025/06/29/nextcell-pharma-completes-patient-dosing-in-pediatric-diabetes-stem-cell-study/) - The company has concluded dosing in its largest pediatric diabetes trial, evaluating ProTrans therapy's safety and insulin-preserving potential - The Regen Report
- [Longeveron Gains FDA Approval to Begin Phase 2 Stem Cell Trial for Children with Heart Disease](https://theregenreport.com/2025/07/09/longeveron-gains-fda-approval-to-begin-phase-2-stem-cell-trial-for-children-with-heart-disease/) - Longeveron will evaluate if it's stem cell candidate, laromestrocel, could target pediatric dilated cardiomyopathy - The Regen Report
- [New Study: Extracellular Vesicles in Fibrin Gel for Cartilage Repair (Italy)](https://theregenreport.com/2025/05/22/new-study-extracellular-vesicles-in-fibrin-gel-for-cartilage-repair-italy/) - The Italian researchers will do a 51 person trial with MSC-derived EVs in PRP-derived fibrin gels. - The Regen Report
- [Hematopoietic Stem Cell-Directed Gene Insertion Therapy Gets IND Clearance](https://theregenreport.com/2025/05/18/hematopoietic-stem-cell-directed-gene-insertion-therapy-gets-ind-clearance/) - With FDA clearance secured, Ensoma prepares to launch its Phase 1/2 clinical trial to establish safety, efficacy, and dosing. - The Regen Report
- [BlueRock Therapeutics Begins Phase 1/2a Trial of Stem Cell Therapy OpCT-001 for Retinal Diseases](https://theregenreport.com/2025/07/11/bluerock-therapeutics-begins-phase-1-2a-trial-of-stem-cell-therapy-opct-001-for-retinal-diseases/) - The Bayer owned company just starting dosing patients with OpCT-001, an iPSC-derived cell therapy aiming to restore vision in inherited retinal diseases. - The Regen Report
- [First patient dosed in Idopathic Pulmonary Fibrosis peptide Phase 2 from Rein Therapeutics](https://theregenreport.com/2025/06/01/first-patient-dosed-in-idopathic-pulmonary-fibrosis-peptide-phase-2-from-rein-therapeutics/) - The Phase 2 trial RCT will evaluate adverse event and efficacy endpoints. - The Regen Report
- [Organ donor? That may include using your stem cells: first successful transplant using deceased donor in blood Cancer clinical trial](https://theregenreport.com/2025/05/26/organ-donor-that-may-include-using-your-stem-cells-first-successful-transplant-using-deceased-donor-in-blood-cancer-clinical-trial/) - It's interesting to consider, much like with umbilical cords, how often are we incinerating life-saving stem cells? - The Regen Report
- [Lineage Cell Therapeutics' Spinal Cord Injury Stem Cell Trial, New Delivery Device](https://theregenreport.com/2025/05/13/lineage-cell-therapeutics-spinal-cord-injury-stem-cell-trial-new-delivery-device/) - The new DOSED trial will explore a novel delivery method for OPC1 cells, potentially bringing hope to chronic SCI patients. - The Regen Report
- [Case Series: Wharton’s Jelly for Neuropathy from Tarsal Tunnel](https://theregenreport.com/2025/02/28/case-series-whartons-jelly-for-neuropathy-from-tarsal-tunnel/) - Link to study, found in the journal named Reports, dated 2024. The problem? Neuropathy of the lower leg caused by tarsal tunnel syndrome Symptoms include Sharp shooting pain Pins/needles Electric shock/burning sensations The treatment studied? Wharton’s Jelly injected into the foot/leg Patients Studied? 8 patients with “tarsal tunnel-related defects” Author Info? Led by Dr. Ronald - The Regen Report
- [AMSBIO unveils StemFit® for Differentiation, a GMP-grade medium for differentiating human induced pluripotent stem (hiPS) and embryonic stem (hES) cells](https://theregenreport.com/2025/03/16/amsbio-unveils-stemfit-for-differentiation-a-gmp-grade-medium-for-differentiating-human-induced-pluripotent-stem-hips-and-embryonic-stem-hes-cells/) - AMSBIO has introduced its GMP-grade StemFit® for Differentiation, a medium designed for the differentiation of human induced pluripotent stem (hiPS) and embryonic stem (hES) cells. This formulation, now compliant with Good Manufacturing Practices (GMP), is intended to support clinical applications by eliminating animal-derived components and minimizing immunogenic risks. The company reports that StemFit® ensures lot-to-lot - The Regen Report
- [BioGenCell Nabs FDA Fast Track Designation for Critical Limb Threatening Ischemia Cell Therapy, BGC101](https://theregenreport.com/2025/04/14/biogencell-nabs-fda-fast-track-designation-for-critical-limb-threatening-ischemia-cell-therapy-bgc101/) - BioGenCell's lead candidate BGC101 receives FDA Fast Track Designation, accelerating development of its personalized cell therapy to prevent amputations in severe CLTI patients. - The Regen Report
- [MEDIPOST preparing for Phase 3 clinical trials of its umbilical cord stem cell product, Cartistem, appoints 5 new executives](https://theregenreport.com/2025/02/27/medipost-preparing-for-phase-3-clinical-trials-of-its-umbilical-cord-stem-cell-product-cartistem-appoints-5-new-executives/) - South Korea's MEDIPOST, Inc., a company developing stem cell-based therapeutics, has announced the appointment of five senior executives, which they say will bring decades of expertise in biologics and cell & gene therapy. This development is part of the company’s efforts as it introduces its regenerative therapy, CARTISTEM®, to patients in the U.S. and aims - The Regen Report
- [Korean Company Launches iPSCs Osteoarthritis Trial](https://theregenreport.com/2025/05/13/korean-company-launches-ipscs-osteoarthritis-trial/) - Biotech company YiPSCELL breaks ground on a new trial, will head to safety & efficacy trials soon. - The Regen Report
- [XSTEM's knee Osteoarthritis stem cell trial: mid-study update, safety and positive efficacy](https://theregenreport.com/2025/05/18/xstems-mid-study-update-on-knee-osteoarthritis-stem-cell-study-showing-safety-and-positive-efficacy/) - Interestingly, it appears that the higher the dose, the better the outcome. So far so good... who will win the Knee OA stem cell battle? - The Regen Report
- [New trial: Umbilical-derived stem cells for knee cartilage](https://theregenreport.com/2025/06/01/new-trial-umbilical-derived-stem-cells-for-knee-cartilage/) - This small German biotech company is joining the knee OA stem cell race. - The Regen Report
- [Celularity gets 361 nod from FDA for its amniotic derived wound care products, Natalin and Acelagraft™ ](https://theregenreport.com/2025/02/28/celularity-gets-361-nod-from-fda-for-its-amniotic-derived-wound-care-products-natalin-and-acelagraft/) - Celularity Inc. (Nasdaq: CELU), a regenerative and cellular medicine company, announced that it received recommendation letters from the FDA's Tissue Reference Group (TRG), regarding its Natalin and Acelagraft™ products confirming that each product “appears to meet all the criteria for regulation solely under section 361 of the PHS Act and the regulations in 21 CFR part 1271.” - The Regen Report
- [Intranasal Stem Cell Therapy: A Nasal Gateway to the Brain Shows Promise for CNS Diseases](https://theregenreport.com/2025/07/13/intranasal-stem-cell-therapy-a-nasal-gateway-to-the-brain-shows-promise-for-cns-diseases/) - For decades, treating diseases of the central nervous system (CNS) with stem cells has been hampered by one persistent biological obstacle: the blood–brain barrier (BBB). While the BBB protects the brain from harmful substances, it also blocks most drugs and cell therapies, making the treatment of conditions like Parkinson’s disease, Alzheimer’s disease, and stroke extremely - The Regen Report
- [Sana Biotechnology Reports Positive Results in Type 1 Diabetes Study Using Transplantation Without Immunosuppression](https://theregenreport.com/2025/07/13/sana-biotechnology-reports-positive-results-in-type-1-diabetes-study-using-transplantation-without-immunosuppression/) - Sana Biotechnology reported six-month clinical data demonstrating successful survival and function of transplanted islet cells without immunosuppressive medication. - The Regen Report
- [FDA Reevaluating ALS Stem Cell Data following Citizen Petition - NurOwn from BrainStorm Cell Therapeutics](https://theregenreport.com/2025/07/13/fda-reevaluating-als-stem-cell-data-following-citizen-petition-nurown-from-brainstorm-cell-therapeutics/) - The FDAs new faces are feeling the pressure from patients and advocates on speeding up potential ALS therapies - The Regen Report
- [CellProthera Selects CELLforCURE to Manufacture Stem Cells for Phase 3 Heart Failure Study](https://theregenreport.com/2025/06/29/cellprothera-selects-cellforcure-to-manufacture-stem-cells-for-phase-3-heart-failure-study-3/) - CellProthera is gearing up for Phase 3 cardiac regeneration trials, moving one step closer to producing clinical batches of ProtheraCytes®, it's stem cell candidate - The Regen Report
- [STEMCELL Technologies Acquires Cellular Highways to Enhance Cell Sorting Technology](https://theregenreport.com/2025/06/29/stemcell-technologies-acquires-cellular-highways-to-enhance-cell-sorting-technology/) - The acquisition is expected to help expand its cell therapy capabilities, gaining advanced microfluidic cell sorting tech for enhanced research - The Regen Report
- [BioRestorative reports Good Preliminary Data for FDA-Fast-Tracked Stem Cell Therapy for Disc Disease](https://theregenreport.com/2025/06/18/biorestorative-reports-good-preliminary-data-for-fda-fast-tracked-stem-cell-therapy-for-disc-disease/) - BioRestorative's early Phase 2 trial results show notable improvements in function and pain for chronic lumbar disc disease patients, moving one step closer to a BLA. - The Regen Report
- [Ensoma nabs IND from the FDA for first in-vivo HSC-directed gene insertion therapy](https://theregenreport.com/2025/06/01/ensoma-nabs-ind-from-the-fda-for-first-in-vivo-hsc-directed-gene-insertion-therapy/) - With FDA approval secured, Ensoma prepares to advance its groundbreaking in vivo therapy into clinical trials targeting X-CGD patients. - The Regen Report
- [TreeFrog Therapeutics nabs €30M in funding to accelerate its iPSC technology, planning Parkinson's trial in 2027](https://theregenreport.com/2025/06/01/treefrog-therapeutics-nabs-e30m-in-funding-to-accelerate-its-ipsc-technology-planning-parkinsons-trial-in-2027/) - TreeFrog has developed a proprietary iPSC manufacturing process called C-Stem, moving one step closer to human trials. - The Regen Report
- [Parkinson's stem cell trial launches: Aspen Neuroscience doses first patient with iPSCs](https://theregenreport.com/2025/05/26/parkinsons-stem-cell-trial-launches-aspen-neuroscience-doses-first-patient-with-ipscs/) - A new milestone for iPSC therapy in the USA, this is one to watch. - The Regen Report
- [Stem cell-based alternative to in vitro maturation reports double the pregnancy rate](https://theregenreport.com/2025/05/27/stem-cell-based-alternative-to-in-vitro-maturation-reports-double-the-pregnancy-rate/) - The company uses iPSCs to create a replica environment for maturing eggs ex vivo, and the data looks promising as they roll into Phase 3. - The Regen Report
- [Stem cell trial for early Alzheimer’s disease to begin at UTHealth Houston, will use Hope Biosciences' technology](https://theregenreport.com/2025/05/13/stem-cell-trial-for-early-alzheimers-disease-to-begin-at-uthealth-houston-will-use-hope-biosciences-technology/) - Will adipose stem cell therapy hold an answer for neuroinflammation, a factor in Alzheimer's? - The Regen Report
- [BlueRock Therapeutics advances to Phase III trial for Parkinson's disease iPSC therapy](https://theregenreport.com/2025/03/02/bluerock-therapeutics-advances-to-phase-iii-trial-for-parkinsons-disease-ipsc-therapy/) - Phase III exPDite-2 trial follows completion and discussion of Phase I trial data with US FDA under Regenerative Medicine Advanced Therapy (RMAT) designation exPDite-2 is a randomized, sham surgery-controlled double-blind trial assessing efficacy and safety of bemdaneprocel in people living with moderate Parkinson’s disease Expected to be initiated in H1 2025, exPDite-2 is the first - The Regen Report
- [Pandorum teams up with AGC Biologics to make stem cell exosomes for Ulcerative Corneal Blindness](https://theregenreport.com/2025/03/03/pandorum-teams-up-with-agc-biologics-to-make-exosomes-for-ulcerative-corneal-blindness/) - Pandorum and AGC have teamed up to produce Pandorum's flagship exosome product Kuragenx, which they refer to as a 'liquid cornea'. Pandorum says that Kuragenx has demonstrated promising results in the preclinical stage, enabling restoration of functional corneas affected by advanced neurotrophic keratitis (NK) - an ulcerative form of corneal blindness and was awarded Orphan - The Regen Report
- [FDA approves new nerve repair product from Orthocell](https://theregenreport.com/2025/04/30/fda-approves-new-nerve-repair-product-from-orthocell/) - With FDA approval now secured, Orthocell prepares to launch Remplir into the lucrative US nerve repair market, accelerating commercialisation. - The Regen Report
- [QC Kinetix Increases Standard PRP Dosing to 10 Billion Platelets](https://theregenreport.com/2025/05/12/qc-kinetix-increases-standard-prp-dosing-to-10-billion-platelets/) - They'll roll out the 10B platelet dosing across all 176 locations in the USA, along with blood analysis/patient registry to measure the outcome data. Looking forward to hearing about this. - The Regen Report
- [Phase III Stem Cell Trial for Epilepsy Launching This Year from Neurona Therapeutics](https://theregenreport.com/2025/05/13/phase-iii-stem-cell-trial-for-epilepsy-launching-this-year-from-neurona-therapeutics/) - This follows their RMAT designation, and promising Phase 1/2 trial results, which they presented earlier this year. - The Regen Report
- [Cellino’s iPSC Manufacturing Tech Receives FDA Advanced Manufacturing Technology (AMT) Designation](https://theregenreport.com/2025/05/22/cellinos-ipsc-manufacturing-tech-receives-fda-advanced-manufacturing-technology-amt-designation/) - With this designation secured, Cellino is looking to accelerate the commercialization of personalized regenerative therapies. - The Regen Report
- [Organogenesis to open $100M biotech facility in Rhode Island, will resume Dermagraft production](https://theregenreport.com/2025/05/22/organogenesis-to-open-100m-biotech-facility-in-rhode-island-will-resume-dermagraft-production/) - The company will produce its FDA-approved diabetic foot ulcer product and others at the new facility, creating over 200 full-time jobs. - The Regen Report
- [BrainChild Bio granted FDA RMAT designation for its CAR T-cell therapy for incurable pediatric brain tumors](https://theregenreport.com/2025/05/22/brainchild-bio-granted-fda-rmat-designation-for-its-car-t-cell-therapy-for-incurable-pediatric-brain-tumors/) - The company plans on moving to Phase 2 later this year, hopefully supporting a BLA in the near future. - The Regen Report
- [I Peace brings Japanese industrial-scale iPSC production to the USA, reporting lower production cost](https://theregenreport.com/2025/05/18/i-peace-brings-japanese-industrial-scale-ipsc-production-to-the-usa-reporting-significantly-lower-production-cost/) - The company has brought its Japanese manufacturing technology to the USA, and claims this will help provide much biologically younger cell therapies to Americans. - The Regen Report
- [Thermo Fisher Scientific launches new cell therapy development center in San Diego](https://theregenreport.com/2025/05/18/thermo-fisher-scientific-launches-new-cell-therapy-development-center-in-san-diego/) - The new Carlsbad facility will provide researchers with critical tools, expertise, and support to rapidly advance cell therapies toward clinical manufacturing. - The Regen Report
- [Safety and Efficacy of Epicardial Implantation of Collagen Membranes with Allogeneic Adipose-Derived Stem Cells (Cardiomesh)](https://theregenreport.com/2025/05/17/safety-and-efficacy-of-epicardial-implantation-of-collagen-membranes-with-allogeneic-adipose-derived-stem-cells-cardiomesh/) - This study will evaluate if the VB-C01 cellularised patch, a collagen membrane seeded with allogeneic adipose-derived stem cells, is safe and effective for surgical epicardial implantation in patients undergoing coronary artery bypass grafting (CABG) who are at high risk of developing heart failure. Researchers will enroll 10 participants in this phase I open-label clinical trial. - The Regen Report
- [iPSC-Derived Motor Neuron Cells' Dose Escalation Trial for Subacute Spinal Cord Injury, a Phase I](https://theregenreport.com/2025/05/17/ipsc-derived-motor-neuron-cells-dose-escalation-trial-for-subacute-spinal-cord-injury-a-phase-i/) - This study will evaluate if allogeneic human induced pluripotent stem cell (iPSC)-derived motor neuron progenitor cells (XS228, made by XellSmart) can safely and effectively treat subacute spinal cord injury. Researchers at the Third Affiliated Hospital, Sun Yat-Sen University, in collaboration with XellSmart Biomedical (Suzhou) Company, will administer XS228 cell injections in a Phase I dose-escalation - The Regen Report
- [ALS Stem Cell Trial: Efficacy and Safety of NurOwn in Early & Moderate ALS (ENDURANCE STUDY)](https://theregenreport.com/2025/05/17/als-stem-cell-trial-efficacy-and-safety-of-nurown-in-early-moderate-als-endurance-study/) - Brainstorm Therapeutics is back, and they've learned a lot from their previous trials. If you don't know the history of Nurown, their ALS stem cell candidate, it showed early promise in Phase 2 with some slowed disease progression. In Phase 3, it failed to meet its primary endpoint, however, a post-hoc analysis suggested potential benefit - The Regen Report
- [Maryland Stem Cell Research Fund Awards Over $18 Million for Regenerative Medicine Development](https://theregenreport.com/2025/05/13/maryland-stem-cell-research-fund-awards-over-18-million-to-drive-breakthroughs-in-regenerative-medicine/) - This latest funding round will hopefully empower more research, trials, and commercialization. - The Regen Report
- [Applied StemCell Submits iPSC Drug Master File to the FDA](https://theregenreport.com/2025/05/12/applied-stemcell-submits-ipsc-drug-master-file-to-the-fda/) - This milestone may bring us closer to regulatory-ready iPSCs. - The Regen Report
- [Nikon CeLL Innovation and RoosterBio team up to develop stem cell manufacturing platform in Japan](https://theregenreport.com/2025/04/30/nikon-cell-innovation-and-roosterbio-team-up-to-develop-stem-cell-manufacturing-platform-in-japan/) - This collaboration plans to accelerate Japan's regenerative medicine landscape, delivering scalable MSC and EV therapies through state-of-the-art manufacturing technologies. - The Regen Report
- [Chinese stem cell (iPSC) therapies receive Phase I trial clearance for ALS & Parkinson's](https://theregenreport.com/2025/04/26/chinese-stem-cell-ipsc-therapies-receive-phase-i-trial-clearance-for-als-parkinsons/) - They'll be using allogeneic iPSCs to treat neurodegenerative disorders. ALS stem cells can be a tough topic after the Nurown trials... are iPSCs the answer? - The Regen Report
- [New Stem Cell R&D Lab by Cell BioEngines](https://theregenreport.com/2025/04/30/new-stem-cell-rd-lab-by-cell-bioengines/) - The new facility at CEPM positions Cell BioEngines to accelerate research and forge partnerships advancing innovative cell therapies. - The Regen Report
- [Cellino and Karis Bio working on first-in-human clinical trial of induced pluripotent stem cells (iPSCs) for cardiovascular diseases](https://theregenreport.com/2025/04/22/cellino-and-karis-bio-working-on-first-in-human-clinical-trial-of-induced-pluripotent-stem-cells-ipscs-for-cardiovascular-diseases/) - The collaboration aims to leverage innovative biomanufacturing technology to accelerate personalized therapies for cardiovascular patients worldwide. - The Regen Report
- [New York Blood Center Enterprises and Human Life CORD sign agreement to expand umbilical-derived mesenchymal stem cell manufacturing in the West](https://theregenreport.com/2025/04/22/new-york-blood-center-enterprises-and-human-life-cord-sign-agreement-to-expand-umbilical-derived-mesenchymal-stem-cell-manufacturing-in-the-west/) - Leveraging NYBCe's CDMO subsidiary, the companies plan on bridging the gap between Asian and American manufacturing standards. This collaboration seeks to tackle industry-wide GMP capacity challenges, making advanced cell therapies more accessible worldwide - The Regen Report
- [Japan says iPSCs ready for mainstream adoption, in final approval stages to cover stem cell therapy for retinas under national health insurance](https://theregenreport.com/2025/02/27/japan-says-ipsc-ready-for-mainstream-adoption-in-final-approval-stages-to-cover-stem-cell-therapy-for-retinas-under-national-health-insurance/) - Japan is reportedly in the final stages of approving the first induced pluripotent stem cell (iPS cell) treatment for inclusion in its national healthcare system. Approval would position Japan among the first countries to integrate iPS procedures into its healthcare coverage. The treatment targets a rare, incurable eye disease that leads to vision loss, and - The Regen Report
- [Allogene Therapeutics Receives Three FDA Fast Track Designations for Lupus, Myositis, and Scleroderma Allogeneic CAR T Therapies](https://theregenreport.com/2025/04/14/allogene-therapeutics-receives-three-fda-fast-track-designations-for-lupus-myositis-and-scleroderma-allogeneic-car-t-therapies/) - Allogene Therapeutics' dual-targeted CAR T therapy, ALLO-329, receives three FDA Fast Track designations, accelerating development for severe autoimmune conditions including lupus, myositis, and systemic sclerosis. - The Regen Report
- [Bayer's BlueRock Therapeutics receives FDA Fast Track Designation for its iPSC OpCT-001 for primary photoreceptor diseases](https://theregenreport.com/2025/04/14/bayers-bluerock-therapeutics-receives-fda-fast-track-designation-for-its-ipsc-opct-001-for-primary-photoreceptor-diseases/) - This milestone positions BlueRock Therapeutics to accelerate clinical development of OpCT-001, aiming to restore vision in patients facing irreversible blindness. - The Regen Report
- [STEMCELL Technologies nabs $49.9 Million investment from Canadian Government](https://theregenreport.com/2025/04/14/stemcell-technologies-nabs-49-9-million-investment-from-canadian-government/) - The funds will help expand and secure Canada's cell based therapy supply chain. - The Regen Report
- [Made Scientific investing $12M to expand stem cell plant in New Jersey](https://theregenreport.com/2025/04/14/made-scientific-investing-12m-to-expand-stem-cell-plant-in-new-jersey/) - The new Princeton facility will boost BioCentriq's capacity, helping clients accelerate innovative cell therapies from development to commercialization. - The Regen Report
- [First FDA-approved stem cell therapy, Ryoncil, now available. Medicaid coverage coming soon](https://theregenreport.com/2025/04/14/first-fda-approved-stem-cell-therapy-ryoncil-now-available-medicaid-coverage-coming-soon/) - A significant milestone for the stem cell industry, likely paving the way for future stem cell based therapies. - The Regen Report
- [Japan startup applies for approval of iPS cell therapy for heart disease](https://theregenreport.com/2025/04/09/japan-startup-applies-for-approval-of-ips-cell-therapy-for-heart-disease/) - Clinical trials involving eight patients showed improvements in symptoms and cardiac function. - The Regen Report
- [BrainStorm Cell Therapeutics Gearing Up for Phase 3b Trial of NurOwn, Its ALS Stem Cell Therapy, Submits IND Amendment](https://theregenreport.com/2025/04/14/brainstorm-cell-therapeutics-gearing-up-for-phase-3b-trial-of-nurown-its-als-stem-cell-therapy-submits-ind-amendment/) - The amended IND application moves NurOwn® closer to initiation of the pivotal Phase 3b clinical trial for ALS patients. - The Regen Report
- [MEDIPOST’s stem cell therapy regenerates stronger cartilage than microdrilling, clears path to US phase 3](https://theregenreport.com/2025/03/27/mediposts-stem-cell-therapy-regenerates-stronger-cartilage-than-microdrilling-clears-path-to-us-phase-3/) - Recent clinical data presented at the AAOS 2025 Annual Meeting in San Diego suggest that MEDIPOST's stem cell therapy, Cartistem, may offer a more effective treatment for severe knee osteoarthritis (OA) compared to traditional microdrilling techniques. The study tracked 25 patients and found that Cartistem helped regenerate stronger cartilage, potentially providing a better alternative for - The Regen Report
- [Korea's 'JointStem' Adipose Stem Cell Therapy gets FDA Breakthrough Therapy Designation for Osteoarthritis](https://theregenreport.com/2025/04/08/koreas-jointstem-adipose-stem-cell-therapy-gets-fda-breakthrough-therapy-designation-for-osteoarthritis/) - Nature Cell Co., Ltd. announced that its cell therapy product, JointStem, has been granted Breakthrough Therapy Designation (BTD) by the U.S. FDA, marking a first for a Korean company in this field. This designation is expected to expedite the development and approval process of JointStem, which is currently undergoing clinical trials in the United States. - The Regen Report
- [Stem Cell and Exosome Trials are Hoping to Tackle Parkinson's](https://theregenreport.com/2025/03/16/stem-cell-and-exosome-trials-are-hoping-to-tackle-parkinsons/) - In March this year, a ScienceDaily article reported that Mass General is pioneering a Phase 1 clinical trial advancing stem cell therapies for Parkinson's disease. The trial involves reprogramming patients' own stem cells into dopamine-producing neurons to replace those lost to the disease. The hospital reports that three of six participants have been treated, with - The Regen Report
- [Garuda Therapeutics Nabs $50 Million Series A-1 Financing for Off-the-Shelf Blood Stem Cell Therapies](https://theregenreport.com/2025/04/08/garuda-therapeutics-nabs-50-million-series-a-1-financing-for-off-the-shelf-blood-stem-cell-therapies/) - New funds aim to advance Garuda’s pipeline toward clinical trials, expand manufacturing capabilities, and support operational growth. - The Regen Report
- [NASA awards $3.1M grant to continue studying stem cells aboard International Space Station](https://theregenreport.com/2025/03/27/nasa-awards-3-1m-grant-to-continue-studying-stem-cells-aboard-international-space-station/) - The National Stem Cell Foundation (NSCF) has received a $3.1 million grant from NASA to further its research on neurodegenerative diseases aboard the International Space Station (ISS). This funding will support additional ground research and facilitate three more missions to the ISS through 2027. The NSCF reports that the award will allow additional ground research - The Regen Report
- [MIT engineers turn skin cells directly into neurons for cell therapy](https://theregenreport.com/2025/03/27/mit-engineers-turn-skin-cells-directly-into-neurons-for-cell-therapy/) - MIT researchers have developed a new method to convert skin cells directly into neurons, bypassing the pluripotent stem cell stage in iPSC development. This technique, demonstrated in mouse cells, could potentially lead to treatments for spinal cord injuries and mobility-impairing diseases if successfully replicated in human cells. MIT reports that this new method, tested on - The Regen Report
- [Stem Cell Expansion System: Terumo and Akron Bio Publish Results Showing Equivalency From Research to Manufacturing Grade Stem Cell Expansion Fibronectin](https://theregenreport.com/2025/03/20/stem-cell-expansion-system-terumo-and-akron-bio-publish-results-showing-equivalency-from-research-to-manufacturing-grade-stem-cell-expansion-fibronectin/) - Terumo Blood and Cell Technologies (Terumo BCT) and Akron Bio say they've completed a collaborative study demonstrating equivalency between research-use-only (RUO) and Good Manufacturing Practices (GMP)-grade fibronectin for expanding mesenchymal stem cells (MSCs) on the Quantum Flex™ Cell Expansion System. The goal of the study was to address one of the longstanding bottlenecks in MSC - The Regen Report
- [Luxa Biotechnology Reports Significant Results in Dry Age-Related Macular Degeneration Stem Cell Trial](https://theregenreport.com/2025/03/15/luxa-biotechnology-reports-significant-results-in-dry-age-related-macular-degeneration-stem-cell-trial/) - Luxa Biotechnology LLC has shared clinical data from its Phase 1/2a trial of RPESC-RPE-4W, a retinal pigment epithelium cell therapy for dry age-related macular degeneration (dry AMD). On the trial page, they mention that "RPESC-RPE-4W is Allogeneic RPE stem cell (RPESC)-derived RPE cells (RPESC-RPE) isolated from the RPE layer of human cadaveric eyes are transplanted - The Regen Report
- [Pharmaceutical giant GSK sees stem cells as useful for drug discovery and therapeutics](https://theregenreport.com/2025/03/08/pharmaceutical-giant-gsk-sees-stem-cells-as-useful-for-drug-discovery/) - In a recent policy position statement, GlaxoSmithKline (GSK) mentioned that stem cell technology has its use cases in drug discovery, albeit it needs to be done in an ethical, safe way. Here's what they said: Stem cells are an integral element of research in drug discovery. GSK currently uses human pluripotent stem cells as well - The Regen Report
- [New rotator cuff repair tech: Atreon Orthopedics gets FDA 510(k) clearance and full market launch of BioCharge® Autobiologic Matrix](https://theregenreport.com/2025/03/07/new-rotator-cuff-repair-tech-atreon-orthopedics-gets-fda-510k-clearance-and-full-market-launch-of-biocharge-autobiologic-matrix/) - Colombus-based Atreon Orthopedics says they've received 510(k) clearance from the FDA for its BioCharge® Autobiologic Matrix. This bioresorbable synthetic implant is designed to address biological failure modes in rotator cuff repair, potentially improving repair integrity and long-term patient outcomes. BioCharge Design and Functionality BioCharge is an onlay scaffold with the following objectives: Kickstart the Patient's - The Regen Report
- [EXO Biologics reportedly Europe's first GMP certified stem cell exosome plant, hits new milestones in mRNA/DNA payloads](https://theregenreport.com/2025/02/28/exo-biologics-reportedly-europes-first-gmp-certified-exosome-plant-hits-new-milestones-in-mrna-dna-payloads/) - European Exosome maker EXO Biologics and its CDMO subsidiary, ExoXpert, say they're the first European CDMO specializing in exosomes to receive Good Manufacturing Practice (GMP) certification. In addition, EXO Biologics says it has managed to achieve the loading of GMP-grade exosomes with mRNA and DNA payloads, a major milestone for the development of exosome-based therapies. - The Regen Report
- [Alpine Spine & Orthopedics adds advanced imaging C-arm for regenerative orthopedic injections in Utah](https://theregenreport.com/2025/03/04/alpine-spine-orthopedics-adds-advanced-imaging-c-arm-for-regenerative-orthopedic-injections-in-utah/) - Alpine Spine & Orthopedics, a regenerative medicine clinic in Utah, has added a new C-Arm from Siemens, the Ciartic Move 3D imaging system. Alpine reports that this system is among the most advanced of its kind, providing ultra-high-resolution 3D imaging with robotically guided movements. By using the new tech, the clinic hopes to overcome many - The Regen Report
- [Cellino launches stem cell "Foundry" at Mass General](https://theregenreport.com/2025/03/04/cellino-launches-stem-cell-foundry-at-mass-general/) - Cellino announced it has launched what they report as the world's first hospital-based autologous induced pluripotent stem cell (iPSC) plant at Mass General Brigham’s Gene and Cell Therapy Institute (GCTI). They are calling it the "Foundry". iPSCs, in short, are adult cells that have been reprogrammed into stem cells, which can turn into any tissue - The Regen Report
- [Florida Republicans introduce two bills to allow umbilical stem cell therapy: Here's what you should know](https://theregenreport.com/2025/03/04/florida-republicans-introduce-two-bills-to-allow-umbilical-stem-cell-therapy/) - Following Utah's bills allowing clinics to offer umbilical stem cell therapy in 2024, Florida looks to do the same. The two bills, SB 1768 and HB 1617 were introduced by Republican representatives Jay Trumbull and James Buchanan. If they pass, Florida will seemingly go against the FDA's guidelines and allow for umbilical cord stem cell - The Regen Report
- [Study: Expanded Wharton’s Jelly for Knee Osteoarthritis with Before/After MRI Data](https://theregenreport.com/2025/02/28/study-expanded-whartons-jelly-for-knee-osteoarthritis-with-before-after-mri-data/) - Link to study, found in the Regenerative Medicine Journal, dated August 2021. The problem? Knee osteoarthritis The treatment studied? 2 injections of 40 million expanded (passage 3) Wharton's Jelly mesenchymal stem cells Ultrasound guidance injection into the knee joint, 1 month between injections Patients Studied? 16 patients aged 42-73 with knee osteoarthritis, with 12-month MRI - The Regen Report

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- [Peptides](https://theregenreport.com/tag/peptides/)
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