The analyses track skeletal muscle and heart outcomes through 24 months in 82 of 106 randomized participants, including delayed-start and natural-history comparisons submitted with a regulatory amendment.
Researchers can use a validated workflow that covers tissue preparation, culture, electrical stimulation and contractility testing in 3D engineered heart tissue made from human stem cell-derived cardiomyocytes.
In the 40-infant randomized, double-blind trial, patients received a single intramyocardial dose. It did not improve right ventricular ejection fraction at 12 months.
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.
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 company's lead program, HS-001, required open heart surgery, while the new innovation allows for a much simpler, less invasive administration.
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.
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.
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.
With the right secured for stem cell potency, Longeveron is continuing its path forward with clinical trials for several mesenchymal stem cell indications.
The new platforms aim to streamline large-scale production of iPSC-derived cell therapies for new indications.
The latest funding round will support US expansion, new stem cell-derived disease models, and increased manufacturing at its Edinburgh site.
Researchers are testing a minimally invasive stem cell patch that could reduce the need for transplants.
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 Phase 2 study showed good results for placenta-derived cell therapy for diabetic foot ulcers complicated by PAD.
RoosterBio and Secretome advance scalable cell therapy manufacturing with a new 50L bioreactor process for STM-01 clinical trials.
The partnership will support clinical and future commercial supply of RION’s exosome therapies for tissue repair and regenerative medicine.
The new grants will support diverse early-stage research projects, aiming to advance regenerative medicine tools and future therapies.
Capricor Therapeutics is coordinating with the FDA on regulatory steps for its Duchenne therapy, with updates expected soon.
The Crew-11 mission launched on Friday, where they will support studies in stem cell growth, organ tissue, bacteriophage therapy, and advanced computing.
Longeveron will evaluate if it's stem cell candidate, laromestrocel, could target pediatric dilated cardiomyopathy
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
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…
BioCardia plans to move forward with enrollment of up to 39 participants in the United States.
The collaboration aims to leverage innovative biomanufacturing technology to accelerate personalized therapies for cardiovascular patients worldwide.