ExCellThera Inc., along with its subsidiary Cordex Biologics, has been granted conditional marketing approval by the European Commission for Zemcelpro, making it the first cell therapy available for adults with blood cancers who do not have a suitable stem cell donor. This approval applies across all European Union member states, as well as Iceland, Norway, and Liechtenstein. Zemcelpro is developed from the same cord blood unit and includes two components: cryopreserved UM171-expanded CD34+ cells (dorocubicel) and unexpanded CD34– cells. Each year, more than 10,000 people in Europe are diagnosed with blood cancers such as leukemia and myelodysplastic syndromes that require stem cell transplants. However, many struggle to find a matched donor in time, particularly among underrepresented populations.
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Dr. Fabio Ciceri, professor of hematology at Vita-Salute San Raffaele University in Milan, explained that the success of allogeneic stem cell transplantation is often hindered by the lack of donor availability. He emphasized that UM171 Cell Therapy offers an alternative that can be ready when needed, helping to close a critical treatment gap. Patients who cannot receive a timely transplant often face worsening disease, more frequent hospitalizations, and increased dependence on long-term medical care and family support.
Beyond the personal and medical consequences, the absence of stem cell donor access also carries a broader societal burden. Premature deaths result in lost productivity, while families and healthcare systems are impacted emotionally and financially. Dr. J. (Jurjen) Versluis, internist-hematologist and principal investigator at Erasmus MC in Rotterdam, pointed out that thousands of patients every year face life-threatening illness without donor options—Zemcelpro® is designed specifically for them.
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As a one-time therapy with curative potential, Zemcelpro® gives new hope to patients who previously had none. Its use could reduce pressure on overburdened healthcare systems while improving outcomes for patients who would otherwise go untreated. Although availability will vary depending on the reimbursement process in each country, Cordex Biologics is already in discussion with national health authorities and working with leading stem cell transplant centers to provide early access and build a network for administering the treatment.
David Millette, CEO of both ExCellThera and Cordex Biologics, called this authorization a transformative step for patients and clinicians alike. He said it delivers a new transplant option for those who have been left without alternatives. The company is preparing additional regulatory submissions in the United States, Canada, the United Kingdom, and Switzerland. It is also actively seeking partners to help accelerate Zemcelpro®’s rollout across Europe and other international markets. The therapy’s safety profile is consistent with conventional allogeneic stem cell transplants following myeloablative conditioning. Conditional marketing authorization is granted to treatments addressing serious unmet medical needs where full clinical data is still being collected and is subject to annual review.
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