ExCellThera, a global leader in blood stem cell expansion and metabolic fitness, has announced a major regulatory breakthrough: its innovative cell therapy has been granted Status 1 under Germany’s NUB (Neue Untersuchungs- und Behandlungsmethoden) programme.

 

The designation allows hospitals to immediately apply for temporary, supplementary reimbursement, accelerating patient access while broader reimbursement pathways are reviewed. Already, 220 hospitals across Germany have expressed interest in offering Zemcelpro (dorocubicel), in 2026.

 

“NUB Status 1 represents a significant milestone for ExCellThera and Cordex and reflects both the innovative nature of Zemcelpro (dorocubicel) and its benefit in addressing a pressing unmet medical need in allogeneic haematopoietic stem cell transplantation,” said David Millette, CEO of ExCellThera. 

 

“Under its initial label, Zemcelpro (dorocubicel) is indicated for patients with life threatening blood cancers who have limited therapeutic options.”

 

The therapy, also known as UM171 Cell Therapy, recently received conditional marketing authorization from the European Commission for adults with haematological malignancies requiring allogeneic stem cell transplantation when no suitable donor cells are available.

 

Zemcelpro contains UM171-expanded CD34+ cells and unexpanded CD34- cells from the same cord blood unit. It has been tested in 120 patients across the US, Europe, and Canada and has earned orphan drug and regenerative medicine designations from the FDA, as well as orphan medicinal product, ATMP classification, and PRIME status from the EMA.

 

The therapy has shown promise in high-risk acute leukemias and myelodysplasias, including patients with TP53 mutations, those requiring second transplants, and those with refractory disease. A pivotal Phase 3 trial is planned to further evaluate its impact.