Excellthera’s Blood Stem Cell Therapy Nabs NUB Status 1 in Germany

Key findings

• Zemcelpro, a hematopoietic (blood) stem cell therapy, received NUB Status 1 in Germany, which allows reimbursement in German hospitals.
• The therapy supports hematopoietic recovery after myeloablative conditioning in hematologic diseases.

Zemcelpro, also known as dorocubicel, has been granted NUB Status 1 by the German Federal Joint Committee. This designation allows the therapy to be reimbursed in German inpatient care settings under current hospital remuneration systems.

What is Zemcelpro (dorocubicel)?
Zemcelpro is a hematopoietic stem cell therapy designed to restore bone marrow function after intensive myeloablative conditioning (high-dose chemotherapy or radiation therapy that destroys bone marrow stem cells), generally used to prepare patients for hematopoietic stem cell transplantation. The treatment is derived from allogeneic (donor) umbilical cord blood and chemically enhanced to support faster, more effective hematopoietic recovery.

It uses a small molecule, UM171, to expand the number of stem cells while keeping them functionally intact, thereby improving the engraftment of those cells, and reducing some of the complications with delayed recovery.

Understanding NUB Status
The NUB (Neue Untersuchungs- und Behandlungsmethoden) status classification in Germany determines reimbursement for new diagnostic and treatment methods that are not yet included in the standard hospital payment system. Status 1 means the therapy has been recognized for reimbursement without restrictions, enabling its adoption in clinical practice.

Significance of the approval
Receiving NUB Status 1 is an important step towards wider use of Zemcelpro in German hospitals. It ensures reimbursement coverage, which is crucial for hospital uptake and patient access. The decision reflects the regulator’s recognition of the therapy’s potential clinical benefit and alignment with healthcare system requirements.

This update follows ongoing clinical evaluations and regulatory submissions across multiple regions. The German designation complements other approvals and supports forthcoming launches in Europe and beyond.

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