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.
Umbilical cord blood stem cells have been a valuable resource in the fight against more than 80 hematological and oncological diseases. Yet, their clinical use has historically been limited by the relatively small number of cells contained in a single unit, sufficient for pediatric patients, but often inadequate for adults. Zemcelpro® solves this problem by expanding hematopoietic stem cells outside the body before transplant, making it possible to treat larger patients who would otherwise not have access to compatible donors.
“The early results are extremely encouraging,” said Professor Emilian Snarski, hematologist, transplant specialist, and Medical Director at FamiCord Group. “Retrospective data suggest expanded cord blood not only lowers relapse rates but also reduces the risk of graft-versus-host disease compared to many other donor sources. If these outcomes are confirmed in prospective trials, this could be the most significant advance in transplantation since CAR-T therapy—doubling the number of patients who can achieve recovery.”
How Zemcelpro® Works
Zemcelpro® (formerly known as UM171) relies on a proprietary expansion technology that amplifies CD34+ stem cells derived from a single cord blood unit. The therapy combines these expanded stem cells with unaltered companion cells from the same donor sample, creating a personalized graft designed to improve engraftment, immune recovery, and long-term outcomes.
This innovation directly addresses a difficult barrier in stem cell transplantation. Across Europe, more than 10,000 patients each year are diagnosed with blood cancers requiring a transplant, yet many are unable to find viable matches. Cord blood has often been the only viable option, but in many cases, the number of cells available was insufficient for safe use. By enabling smaller cord blood units to become clinically viable, Zemcelpro® substantially broadens access to life-saving therapies.
For FamiCord Group, Europe’s largest family cord blood bank and a company that is developing advanced therapies, the authorization underscores the growing importance of cord blood as a therapeutic tool.
“This milestone validates cord blood’s potential to overcome its long-standing limitations,” said Tomasz Baran, Chief Medical Officer at FamiCord Group. “As both a banking leader and active collaborator in cell therapy research, we see this approval as a breakthrough moment. It offers new hope for patients and strengthens our mission to deliver cutting-edge treatments to families across Europe.”
Conditional Marketing Authorization
The European Commission granted Zemcelpro® a Conditional Marketing Authorization (CMA), a regulatory pathway reserved for medicines that address urgent, unmet medical needs. CMAs allow earlier patient access when the benefits clearly outweigh the risks, even as further clinical data are collected. These authorizations are valid for one year and can be renewed annually following regulatory review.
Zemcelpro® marks a pivotal step in the evolution of transplant medicine. By unlocking the potential of cord blood for broader patient populations, it not only expands the pool of available stem cell donors but also provides novel therapeutic tools to fight to life-threatening diseases. With further trials underway, the therapy may soon redefine the role of cord blood in modern hematology and oncology.
Source: FamiCord
To learn more, view the “Global Cord Blood & Tissue Banking Industry Report – Market Size, Segmentation, Forecasts, Competitors, Opportunities, and Trends, 2025.”