September 10, 2025 — In a landmark move for regenerative medicine, the European Commission has conditionally authorized Zemcelpro®, the first treatment in Europe to use expanded umbilical cord blood stem cells. Developed by Canadian biotech company ExCellThera, this therapy is only the second of its kind approved worldwide and represents a major advance in transplant options for patients with blood cancers such as leukemias and myelodysplastic syndromes. [Read more…]
Stem Cell News
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Congress Moves to Reauthorize Funding for National Cord Blood and Bone Marrow Transplant Programs
Legislation would authorize $280 million over 5 years to support National Cord Blood and Bone Marrow Transplant Programs.
A bipartisan group of lawmakers in the U.S. House has introduced new legislation to extend funding for two cornerstone programs that connect patients with life-saving stem cell treatments. The Stem Cell Therapeutic and Research Reauthorization Act of 2025 proposes more than $280 million in federal funding over the next five years, ensuring that these initiatives continue past their current 2026 expiration date. [Read more…]
Regenerelle® Issues Response to FDA Untitled Letter
Rochester, NY — September 8, 2025 — Regenerelle®, a global leader in the manufacturing and distribution of Wharton’s Jelly Mesenchymal Stromal Cells (WJ-MSCs) and exosomes derived from WJ-MSCs, today announced the public release of its full response to the U.S. Food and Drug Administration (FDA) Untitled Letter dated May 22, 2023.
The disclosure is being made by AT Venture Center, the parent company of Regenerelle, LLC, the regenerative biotherapeutic manufacturing and distribution arm of the company providing stem cells and exosome products to its subsidiaries and distributors serving an extensive connected network of more than 4,000 regenerative medicine and aesthetics professionals worldwide, including MedSpas, orthopedic and pain clinics, wound care centers, and aesthetic practices. [Read more…]
EU Grants Approval to Zemcelpro, a Cord Blood–Derived Stem Cell Therapy for Blood Cancer Patients
In August 2025, the European Commission (EC) granted conditional marketing authorization (CMA) to Cordex Biologics, a subsidiary of ExCellThera, for Zemcelpro® (UM171 Cell Therapy), a personalized stem cell therapy derived from a single cord blood unit for blood cancer patients who lack access to a suitable donor for a traditional transplant. ExCellThera announced the news on August 27, 2025.
Zemcelpro is the first and only allogeneic cell therapy approved in the EU for this patient population. By leveraging ExCellThera’s proprietary UM171 expansion platform, the therapy enhances the viability and functionality of cord blood stem cells, overcoming a decades-long limitation: insufficient cell volume for adult transplantation. As such, Zemcelpro represents a major clinical milestone and a therapeutic breakthrough with the potential to expand the use of cord blood–derived cellular therapies in the EU and beyond. [Read more…]
Precision Over Hype: Biogenomics’ Genovia Sets a New Standard in Exosome-Based Regenerative Aesthetics
Los Angeles, CA – September 4, 2025 – As industry scrutiny intensifies over cosmetic products making bold but unverified “exosome” claims, Biogenomics, a biotech company advancing regenerative aesthetics, has announced performance breakthroughs for its flagship innovation, Genovia. Unlike competitors who emphasize inflated particle counts, Genovia is engineered through a patented lactoferrin-enhanced process that delivers scientifically validated quality, safety, and functional performance.
“Exosomes aren’t about chasing numbers — they’re about results providers can trust and patients can see,” said a Biogenomics spokesperson. “That’s the standard Genovia delivers.” [Read more…]
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