In August 2025, the European Commission (EC) granted conditional marketing authorization (CMA) to Cordex Biologics, a subsidiary of ExCellThera, for Zemcelpro® (UM171 Cell Therapy), a personalized stem cell therapy derived from a single cord blood unit for blood cancer patients who lack access to a suitable donor for a traditional transplant. ExCellThera announced the news on August 27, 2025.
Zemcelpro is the first and only allogeneic cell therapy approved in the EU for this patient population. By leveraging ExCellThera’s proprietary UM171 expansion platform, the therapy enhances the viability and functionality of cord blood stem cells, overcoming a decades-long limitation: insufficient cell volume for adult transplantation. As such, Zemcelpro represents a major clinical milestone and a therapeutic breakthrough with the potential to expand the use of cord blood–derived cellular therapies in the EU and beyond.
A Novel Cord Blood Therapy Leveraging UM171
Each year, more than 10,000 patients in Europe are diagnosed with blood cancers such as acute leukemias and myelodysplastic syndromes that require allogeneic stem cell transplantation. While registries have improved access to donor cells, a significant number of patients are unable to secure a match in time, particularly those from ethnic minority populations. The absence of a suitable donor often leads to rapid disease progression, repeated hospitalizations, and premature mortality.
Zemcelpro directly addresses this unmet need. By enabling cord blood, once dismissed as too small for adult use, to serve as the foundation for a curative transplant, the therapy dramatically expands access to treatment.
What sets Zemcelpro apart is its ability to transform a single cord blood unit into a transplant option for adults. The product contains two cellular components from the same source: UM171-expanded CD34+ cells (dorocubicel), which are enhanced for self-renewal and engraftment potential, and unexpanded CD34- cells, which provide additional support.
This therapy lies in the UM171 molecule, which enables robust expansion of hematopoietic stem cells (HSTs). Zemcelpro overcomes the long-standing problem of low cell dose, unlocking the therapeutic power of cord blood and turning it into a scalable solution for patients who otherwise would not have access to a transplant.
Addressing a Critical Gap in Transplant Medicine
With this approval, Zemcelpro is authorized for use in all EU member states, as well as Iceland, Norway, and Liechtenstein. However, the timing of patient access will depend heavily on national reimbursement processes, which are now underway across Europe. In the meantime, Cordex Biologics is collaborating with health authorities to launch early access programs, while simultaneously developing a network of treatment centers equipped to administer the therapy.
Looking beyond Europe, the company has announced plans to file regulatory submissions in the United States, United Kingdom, Canada, and Switzerland, underscoring its intent to position Zemcelpro as a global therapeutic option. Cordex is also actively pursuing partnerships to accelerate commercialization and scale delivery.
The approval of Zemcelpro is significant for both patients and healthcare systems. By increasing the pool of transplant-eligible patients, it has the potential to reduce the high costs associated with long-term supportive care for those who never receive a transplant. For families, it represents relief from the cycle of hospitalizations and uncertainty that accompany untreated blood cancers. Importantly, it also improves equity in access, offering a viable alternative for patients from minority populations who have historically faced reduced odds of finding a suitable donor.
Clinicians emphasize the therapy’s transformative role. Dr. Fabio Ciceri, Professor of Hematology at Vita-Salute San Raffaele University in Milan, explained: “The curative potential of allogeneic stem cell transplantation is still limited by access to a suitable donor. UM171 Cell Therapy offers an option timely available for patients in need.”
David Millette, CEO of ExCellThera and Cordex Biologics, framed it as a turning point: “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.”
The Future of Zemcelpro
Zemcelpro, derived from a single cord blood unit, represents a major shift in stem cell therapy. By using the UM171 expansion platform to overcome the low cell counts that have limited adult transplants, it broadens patient access and reduces healthcare burden. With first-mover advantage in Europe and plans for global expansion, Cordex Biologics is poised to lead the emerging market for cord blood–derived therapeutics.
FAQs
What is Zemcelpro?
Zemcelpro, also known as UM171 Cell Therapy, is a personalized stem cell product derived from a single cord blood unit.
It contains two components: UM171-expanded CD34+ cells (dorocubicel) and unexpanded CD34- cells from the same unit.
The therapy uses a proprietary molecule, UM171, to expand stem cells and improve their self-renewal capabilities.
How does it work?
Zemcelpro makes smaller cord blood units viable for adult stem cell transplants by increasing the number of functional stem cells. This process overcomes the shortage of matched donors, a significant barrier to treatment for many patients.
Who can access it?
Zemcelpro is authorized for use in all EU member states, as well as Iceland, Norway, and Liechtenstein. ExCellThera plans further regulatory submissions in other countries, including the U.S., UK, Canada, and Switzerland.
The company is also working with national health authorities to provide early access to the therapy while national reimbursement processes are finalized.
