August 27, 2025 — Leads & Copy — ExCellThera Inc. and its subsidiary Cordex Biologics announced that Zemcelpro® has received conditional marketing authorization from the European Commission (EC) for treating adults with haematological malignancies requiring stem cell transplantation when no other suitable donor cells are available. The EC’s decision allows Zemcelpro® to be marketed in all EU member states, as well as Iceland, Norway, and Liechtenstein.
Zemcelpro®, also known as UM171 Cell Therapy, is a personalized cryopreserved haematopoietic stem cell transplantation product comprised of UM171-expanded CD34+ cells and unexpanded CD34- cells from the same cord blood unit. Over 10,000 patients in Europe are diagnosed annually with blood cancers that require stem cell transplants. Zemcelpro® aims to address the unmet need for patients who cannot access suitable donor cells.
Dr. Fabio Ciceri, Professor of Hematology at Vita-Salute San Raffaele University, noted that UM171 Cell Therapy offers a timely option for patients in need, as access to stem cell donation is a major limiting factor for transplant success.
Dr. J. (Jurjen) Versluis, Internist-Hematologist and Principal Investigator at Erasmus MC, added that some patients are left without access to suitable donor-derived blood stem cells, facing a critical and unmet medical need.
According to David Millette, CEO of ExCellThera and Cordex Biologics, the authorization marks a pivotal milestone in delivering the therapeutic promise of Zemcelpro® for adults battling haematological malignancies. Additional regulatory filings are planned for Zemcelpro® in the US, Canada, the UK, and Switzerland. Cordex Biologics is seeking strategic partnerships to accelerate commercialization in Europe and other markets.
The safety profile of Zemcelpro® aligns with conventional allogeneic blood stem cell transplantation following myeloablative conditioning.
For more information, please refer to the EU Summary of Product Characteristics (SmPC) of Zemcelpro®.
Contact:
David Millette, CEO of ExCellThera and Cordex Biologics
Source: ExCellThera
