EU Grants Conditional Approval To Zemcelpro, First Expanded Cord Blood Stem Cell Therapy
(RTTNews) - The European Commission has granted Conditional Marketing Authorization or CMA to Zemcelpro®, developed by ExCellThera - a portfolio company of FamiCord AG (VTIAF), marking Europe's first approved therapy using expanded umbilical cord blood stem cells and the second worldwide.
This innovation significantly improves access to allogeneic stem cell transplants for adults with blood cancers such as leukemias and myelodysplastic syndromes, particularly when no matched donor cells are available.
Cord blood stem cells are used to treat over 80 hematological and oncological diseases but have historically been limited by cell quantity, restricting use mainly to pediatric patients.
Zemcelpro® addresses this by expanding hematopoietic stem cells from a single cord blood unit, enabling use in adult patients. Early studies suggest lower relapse rates and reduced graft-versus-host disease compared to other stem cell sources, with ongoing trials expected to confirm these benefits.
Each year, over 10,000 European patients require stem cell transplants, yet many lack suitable donors. Zemcelpro® allows even small cord blood units to be viable for treatment, potentially doubling the number of patients who can reach full recovery.
FamiCord Group, Europe's largest family cord blood bank and a development partner, called the approval a milestone in global cell therapy, reinforcing cord blood's value as a versatile source of stem cells and offering new hope to patients.
CMAs are granted to therapies addressing unmet medical needs with strong benefit-risk profiles despite incomplete data and are subject to annual renewal with ongoing regulatory review.
Monday VTIAF closed at $5.50 with no movement on the OTC Markets OTCPK.
