ExCellThera Inc. and its subsidiary Cordex Biologics announced that Zemcelpro (UM171 Cell Therapy) has received conditional marketing authorization from the European Commission (EC) for use in adults with blood cancers who need a stem cell transplant but lack access to a suitable donor.
The EC decision enables Zemcelpro to be marketed across all EU member states, as well as Iceland, Norway, and Liechtenstein, offering a crucial treatment option for patients with haematological malignancies—including leukemia and myelodysplastic syndromes—who are eligible for allogeneic stem cell transplant but unable to find compatible donor cells within the therapeutic window.
Zemcelpro is a personalized, cryopreserved cell therapy composed of UM171-expanded CD34+ cells (dorocubicel) and unexpanded CD34- cells, both derived from a single cord blood unit. This innovative approach addresses the longstanding challenge of limited donor availability, especially for patients from underrepresented ethnic backgrounds, who often face additional barriers in the donor-matching process.
“This is a major breakthrough,” said Dr. Fabio Ciceri, Professor of Hematology at Vita-Salute San Raffaele University in Milan. “Zemcelpro provides a timely option for patients with aggressive disease courses who can’t wait for traditional donor matching.”
Each year, over 10,000 patients in Europe require a stem cell transplant for blood cancers. While donor registries have expanded, many still miss the opportunity for transplant due to donor unavailability or timing. These gaps in access contribute to disease progression, hospitalizations, and early death—adding substantial economic and emotional strain on families and healthcare systems.
Dr. J. (Jurjen) Versluis, Principal Investigator at Erasmus MC in the Netherlands, emphasized the unmet need: “Some patients are left with no access to transplant. Zemcelpro is designed to change that.”
David Millette, CEO of ExCellThera and Cordex Biologics, called the EC approval a “pivotal milestone,” noting Zemcelpro is now the first and only authorized cell therapy in Europe specifically for patients without suitable stem cell donors.
Cordex Biologics is working with national health authorities to enable early patient access ahead of full reimbursement and is partnering with leading transplant centers to prepare for clinical rollout. Additional regulatory filings are planned in the United States, Canada, the UK, and Switzerland, as the company explores global commercialization and strategic partnerships.
Zemcelpro®’s safety profile is consistent with traditional allogeneic stem cell transplant procedures, and full prescribing information is available in the EU Summary of Product Characteristics (SmPC).