Developer of stem cell therapeutics and a subsidiary of Elbit Medical Imaging Ltd. (EMI) (Nasdaq: EMITF) - Gamida Cell Ltd. - has reached an agreement under a Special Protocol Assessment (SPA) with the USFDA regarding the design of the global, pivotal, historical controlled, registration study of StemEx® for the treatment of hematological malignancies.
StemEx® is currently under development by Gamida Cell in joint venture with Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA).
Stem cell transplantation is a life saving procedure for patients with high-risk hematological malignancies. Currently, many adult and adolescent patients lack a suitable marrow donor.
Composed of ex-vivo expanded cord blood stem/progenitor cells, which are transplanted in combination with non-expanded cells from the same cord blood unit, StemEx® may provide an alternative source of stem cells for these patients by enabling the use of cord blood for transplantation.
Find more details from the press release.
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