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Zemcelpro®: A Promising Advance in Blood Cancer Treatment

On June 19, 2025, ExCellThera Inc., a leader in blood stem cell therapy, announced a pivotal recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). This positive opinion endorses the conditional marketing authorization of Zemcelpro® (also known as UM171 Cell Therapy) for adults suffering from hematological malignancies who require an allogeneic hematopoietic stem cell transplantation but lack suitable donor cells.

A New Hope for Patients

Zemcelpro® represents a significant breakthrough in treating conditions such as leukemias and myelodysplastic syndromes. For thousands of patients each year, the absence of a matching donor means diminished treatment options and lower survival rates. By potentially increasing access to donor-derived stem cell transplants, Zemcelpro® could provide a curative alternative for these critical cases.

Every year, over 10,000 new cases of hematologic malignancies are diagnosed across Europe, leading many to require bone marrow transplants. The dire reality for some patients is the unavailability of suitably matched donors. This innovation seeks to bridge that gap.

The Science Behind Zemcelpro®

This advanced therapy involves a cryopreserved stem cell transplant product composed of factors derived from umbilical cord blood. Specifically, it contains UM171-expanded CD34+ cells (dorocubicel) along with unexpanded CD34- cells, all sourced from the same cord blood unit. This dual component design is a notable aspect of the therapy, potentially enhancing its effectiveness.

Once approved, Zemcelpro® will be the first and only therapy in the EU authorized for this particular patient demographic, marking a significant milestone in hematological care. The approval decision from the European Commission is anticipated within two months following the CHMP’s recommendation, affecting all EU Member States and several others, including Iceland, Norway, and Liechtenstein.

The Path Forward

Following the favorable CHMP evaluation, ExCellThera plans to submit additional applications to regulatory agencies in the United States, Canada, the United Kingdom, and Switzerland. The company’s commitment to clinical trials has seen Zemcelpro® successfully tested on 120 patients across North America and Europe, showcasing significant potential, especially for those with high-risk acute leukemias and myelodysplastic syndromes.

Dr. Guy Sauvageau, the Chief Scientific Officer (CSO) and founder of ExCellThera, expressed the urgency of addressing the unmet medical needs of patients who are unable to access appropriate stem cell transplants.

“Every year, thousands of individuals in Europe are diagnosed with hematological cancers requiring transplantation,” he stated. The introduction of Zemcelpro® will move us closer to delivering a transformative treatment option for these patients.

Safety and Efficacy Considerations

Zemcelpro® has been recognized with orphan drug designations and advanced therapeutic classifications by major health authorities, including the FDA and EMA, reflecting its potential to address serious unmet medical needs. Its safety profile aligns closely with conventional allogeneic stem cell transplants, providing reassurance about its application in these vulnerable patient groups.

As the project progresses, ExCellThera is also committed to exploring Zemcelpro®’s efficacy across different patient demographics, including children and individuals with non-malignant hematological disorders.

Conclusion

The developments surrounding Zemcelpro® present a beacon of hope for those affected by blood cancers. If fully approved, this groundbreaking treatment could significantly change the outcomes for many, restoring not only health but also hope to countless patients and their families across Europe. With ongoing research and collaboration, the dream of a more accessible and effective treatment could soon become a reality.