Gamida Cell - Cord Blood Transplant

StemEx®

StemEx® is a graft of an expanded population of stem/progenitor cells, derived from part of a single unit of umbilical cord blood and transplanted by IV infusion along with the remaining, non-manipulated cells from the same unit.

Copper chelator technology is used to expand the small number of cord blood stem/progenitor cells, increasing their therapeutic capacity for transplantation in adolescents and adults.

StemEx® was developed by the Gamida Cell-Teva Joint Venture (JV), equally owned by Gamida Cell and Teva Pharmaceutical Industries.

The JV sponsored a Phase II/III, multi-center, multi-national, historical cohort-controlled study to evaluate efficacy and safety of StemEx® as an alternative transplantation treatment for patients with high risk leukemia and lymphoma. Twenty-five bone marrow transplant centers worldwide treating 101 patients with hematologic malignancies following myeloablative therapy who could not find a matched bone marrow donor participated in the study.

While the single arm Phase II/III study, incorporating a historical cohort as the study control, provided evidence of activity of StemEx®, the FDA advised Gamida Cell to conduct another trial – a Phase III, randomized -controlled clinical study.

Gamida Cell and Teva are evaluating next steps in the development of StemEx®.




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