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