August 27, 2025 — Leads & Copy — ExCellThera Inc. and its subsidiary Cordex Biologics have announced that Zemcelpro® received conditional marketing authorization from the European Commission (EC). The authorization is for treating adults with haematological malignancies needing allogeneic haematopoietic stem cell transplantation after myeloablative conditioning, when no other suitable donor cells are available. The EC decision allows Zemcelpro® to be marketed in all EU member states, Iceland, Norway, and Liechtenstein.
Zemcelpro®, also known as UM171 Cell Therapy, is a personalized cryopreserved haematopoietic stem cell transplantation product. It contains UM171-expanded CD34+ cells (dorocubicel) and unexpanded CD34- cells, both from the same cord blood unit.
In Europe, over 10,000 patients are diagnosed annually with haematological malignancies like leukemias and myelodysplastic syndromes requiring stem cell transplants. Many patients cannot access suitable donor cells due to the absence of a compatible donor or the inability to secure donor cells within the necessary therapeutic window.
Dr. Fabio Ciceri from Vita-Salute San Raffaele University in Milan, Italy, noted that access to stem cell donation is a major limiting factor for successful transplants, and UM171 Cell Therapy offers a timely option for patients in need.
Dr. J. Versluis from Erasmus MC in Rotterdam, The Netherlands, stated that some individuals are left without access to suitable donor-derived blood stem cells, facing a critical unmet medical need.
Zemcelpro® is a one-time cell therapy aimed at providing blood cancer patients without suitable donor cells the transplants they need. Cordex Biologics is working with national health authorities to enable early access for eligible patients and is establishing a network of treatment centers.
David Millette, CEO of ExCellThera and Cordex Biologics, said that the authorization marks a pivotal milestone and offers a vital new stem cell transplant option for those without one.
Additional regulatory filings are planned for Zemcelpro® in the US, Canada, the UK, and Switzerland. Cordex Biologics is actively seeking strategic partnerships to accelerate Zemcelpro’s commercialization.
The safety of Zemcelpro® aligns with the safety profile of conventional allogeneic blood stem cell transplantation.
For full details, refer to the EU Summary of Product Characteristics (SmPC) of Zemcelpro®.
Contact: David Millette, CEO of ExCellThera and Cordex Biologics.
