Zemcelpro Stem Cell Therapy Granted EC Conditional Marketing Authorization

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Montreal, Canada-based ExCellThera, a company specializing in blood stem cell expansion and metabolic fitness, and its wholly owned subsidiary Cordex Biologics, announced on Aug. 27, 2025 that it has received conditional marketing authorization by the European Commission (EC) for Zemcelpro, also known as UM171 Cell Therapy, for treating adults with hematological malignancies that require an allogeneic hematopoietic stem cell transplantation following myeloablative conditioning for whom no other type of suitable donor cells is available (1). The authorization applies across the European Union, as well as Iceland, Norway, and Liechtenstein, and marks the first approval of a cell therapy specifically developed for patients without an appropriate donor match.

Zemcelpro is a cryopreserved personalized stem cell transplantation product comprised of two components derived from a single cord blood unit: UM171-expanded CD34+ cells, known as dorocubicel, and unexpanded CD34– cells. Developed by Cordex Biologics, the therapy is intended to address one of the most persistent challenges in transplantation medicine—the shortage of suitable donors.

“The curative potential of allogeneic stem cell transplantation is still limited by the access to a suitable donor. The access to stem cell donation according to the stringent disease course is one of the major limiting factors for success,” said Dr. Fabio Ciceri, professor of Hematology, Vita-Salute San Raffaele University, Milan, Italy, in ExCellThera’s press release (1). “UM171 Cell Therapy offers an option timely available for patients in need.”

What unmet stem cell transplantation needs does Zemcelpro address?

More than 10,000 patients in Europe are diagnosed every year with hematological malignancies, such as leukemias and myelodysplastic syndromes, that may require a transplant (2). Despite advances in donor matching and registry access, many patients still face barriers, including donor unavailability or delays in obtaining cells within the critical therapeutic window. These challenges disproportionately affect individuals from ethnic minority backgrounds.

Zemcelpro highlights the increasing role of advanced cell expansion platforms in tackling limitations of donor-derived therapies. By enabling timely transplants from cord blood units, the therapy demonstrates how ex-vivo stem cell manipulation can extend the applicability of donor sources once considered too limited for widespread use.

“Each year, thousands of people across Europe are diagnosed with blood cancers that require potentially life-saving allogeneic stem cell transplantation. Yet some are left without access to suitable donor-derived blood stem cells, facing a critical and unmet medical need,” said J. (Jurjen) Versluis, MD, PhD, internist-hematologist and principal investigator, Erasmus MC, Rotterdam, The Netherlands, in the release.

Patients who are unable to access transplants represent a significant burden for healthcare systems, as disease progression often leads to higher costs from complications, repeated hospitalizations, and long-term supportive care. According to ExCellThera, Zemcelpro aims to reduce that burden while offering curative intent for patients otherwise excluded from transplant eligibility.

What is the regulatory pathway and future of development for these therapies?

The safety profile of Zemcelpro is consistent with established risks of conventional allogeneic transplants following myeloablative conditioning, ExCellThera stated in its release. The therapy’s conditional authorization reflects the EC’s policy to accelerate access to medicines addressing urgent unmet needs, while requiring further confirmatory data through ongoing clinical trials.

“This authorization marks a pivotal milestone in delivering on the therapeutic promise of Zemcelpro for adults battling life-threatening hematological malignancies. As the first and only cell therapy approved for patients without access to suitable donor cells, Zemcelpro offers a vital new stem cell transplant option—and renewed hope—for those who have been left without one,” said David Millette, CEO of ExCellThera and Cordex Biologics, in the release.

Cordex Biologics plans to work with national health authorities to secure early patient access and establish a network of transplantation centers while reimbursement procedures are finalized. The company is also preparing regulatory submissions in the United States, Canada, the United Kingdom, and Switzerland.

References

1. ExCellThera. Zemcelpro (UM171 Cell Therapy) Receives EC Authorization as the First and Only Cell Therapy for Blood Cancer Patients Without Access to Suitable Donor Cells. Press Release. Aug. 27, 2025.
2. Passweg, J. R.; Baldomero, H.; Ciceri, F.; et al. Hematopoietic Cell Transplantation and Cellular Therapies in Europe 2021. The Second Year of the SARS-CoV-2 Pandemic. A Report from the EBMT Activity Survey. Bone Marrow Transplant. 2023, 58 (6), 647–658. DOI: 10.1038/s41409-023-01943-3.