Webinar: Inside eXmoor’s 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.
Regenerative Medicine News & Intelligence Hub
Cell & Gene Webinars
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...
Webinar: Inside eXmoor’s Cell & Gene GMP Facility, Designed for Uncertainty
eXmoor Pharma's experts will present a case study of capabilities and lessons learned scaling...
Interviews & Articles
Guts & Glory: Both of Cynata’s 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...
Replacing Magnetic Separation with Buoyancy: A Closer Look at Bracco’s New Cell Selection Platform, BubbleGen™
Could a gentler, more scalable method improve how cells are isolated for advanced therapies?...
Interview: From Zero to One, How Terumo’s Ecosystem Blueprint Is Helping Scale Cell Therapies in Asia
Cell and gene therapies are advancing quickly, but the systems needed to deliver them...
Q&A – Inside iDEM, Mytos’ Automated Cell Therapy Manufacturing Platform
Pluripotent stem cell therapies are expensive, upwards of $500K–$1M per dose. Mytos has developed...
Interview: Veterinary Stem Cells – Gallant’s Quest for the First FDA-Approved MSC Therapy
Gallant is betting the future of veterinary regenerative medicine lies in scalable, well-characterized cell...
Chinese Study Reports Intranasal Muse Stem Cells Show Potential for Parkinson’s Treatment
Researchers report that intranasal Muse cells improved motor function and reduced neurodegeneration in a...
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...
FDA’s New Regulatory Pathway May Forego RCTs for Ultra-Rare Conditions
Dr. Marty Makary and Dr. Vinay Prasad publish new article in New England Journal...
Interview: siRNA-Loaded Stem Cell Exosomes, Inside NurExone Biologic’s Spinal Cord Injury Candidate
NurExone's SCI candidate showed 100% gait recovery in rat models, and they're gearing up...
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...
Inside Japan’s Regenerative Medicine Laws: JSRM Explains
What can the world learn from Japan’s regenerative medicine laws? We sat down with...
All The Latest
New rotator cuff repair tech: Atreon Orthopedics gets FDA 510(k) 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...
Hope Biosciences launches stem cell trial for children with arthritis (Juvenile Rheumatoid/Idiopathic 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...
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...
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...
Florida Republicans introduce two bills to allow umbilical stem cell therapy: Here’s what you should know
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...
Pandorum teams up with AGC Biologics to make stem cell 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...
BlueRock Therapeutics advances to Phase III trial for Parkinson’s 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...
EXO Biologics reportedly Europe’s first GMP certified stem cell 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...
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...
BioRestorative Therapies nabs FDA IND clearance for Phase 2 trial of its autologous cultured mesenchymal stem cell therapy, ‘BRTX-100″ for spine conditions
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...
Japan says iPSCs 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...
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...
