This is the only product that has reached the stage of confirmation of clinical development. A single institutional study (phase I study in the M D. as well. Anderson Cancer Center) suggested that the infusion … expanded these cells could improve the outcome of transplant patients large. ” StemEx is a graft of an expanded population of stem / progenitor cells derived from a single unit of umbilical cord blood and transplanted intravenously with the unit remaining unmanipulated cells.
Currently being evaluated in a major international study to register with the FDA, Phase II / III, called ExCell, adolescents and adults at high risk of hematologic neoplasms in hospitals in the U.S., Italy, Spain, Hungary and Israel . (The study was conducted to test the safety and efficacy of this product, comparing the total mortality over a period of 100 days with a historical cohort study of international registrations transplant umbilical cord blood. It also assesses the feasibility of manufacturing and shipping centralized expanded cord blood cells for transplant centers to infuse. The speed and integrity of the grafts and haematological and immunological reconstitution long term receptor will shed a light on the role of expanded UCB cells in transplantation. StemEx is being developed by the joint venture of Gamida Cell and Teva Pharmaceutical Industries (NASDAQ: Teva). Estimated market launch: 2011.
About Gamida Cell Gamida Cell Ltd. is a global leader in stem cell expansion and therapeutic products. The company is developing a series of products for stem cell transplantation and tissue regeneration in order to deal effectively with often fatal diseases such as cancer and blood diseases, autoimmune and ischemic. The candidates include therapeutic Cell Gamida adult stem cell populations, selected non-controversial sources like umbilical cord blood and bone marrow that are expanded by culture. Gamida Cell has managed to make their own expansion technologies in sound production processes and validated in GMP. The flagship of Gamida Cell, StemEx, is now being studied as a therapy for blood cancer patients in a pivotal trial developed international leaders in transplantation centers in the United States, Europe and Israel. StemEx has been designated as an orphan drug in the U.S. and Europe.