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Topline Phase 3 Data. Our proprietary platform allows us to expand multiple cell types — including stem cells and natural killer (NK) cells — while maintaining their original phenotype and potency.
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In May 2020, we reported topline results from an international, multi-center, randomized Phase 3 clinical study in 125 patients demonstrating that omidubicel was generally well tolerated and the median time to neutrophil engraftment was significantly shorter for patients who were randomized to omidubicel than those in the comparator group. 0000005195 00000 n
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The international, multi-center, randomized Phase 3 study (NCT02730299) was designed to evaluate the safety and efficacy of omidubicel in patients with high-risk hematologic malignancies undergoing a bone marrow transplant compared to a comparator group of patients who received a standard umbilical cord blood transplant. 0000673409 00000 n
Explore our pipeline below for information on our clinical development candidates and ongoing clinical trials.Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers).
Omidubicel: An investigational advanced cell therapy 0000700912 00000 n
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Based on the results of the Phase 3 clinical study, the company expects to submit a biologics license application to the FDA by the end of 2020. 0000334570 00000 n
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Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.In May 2020, we reported topline results from an international, multi-center, randomized Phase 3 clinical study in 125 patients demonstrating that omidubicel was generally well tolerated and the median time to neutrophil engraftment was significantly shorter for patients who were randomized to omidubicel than those in the comparator group. 0000697654 00000 n
The international, multi-center, randomized Phase 3 study (NCT02730299) is designed to evaluate the safety and efficacy of omidubicel compared …
Gamida Cell expects to complete patient enrollment in the Phase 3 study by the end of 2019 with topline data anticipated in the first half of 2020. Published May 12, 2020. https://bit.ly/35WbJXO. 0000785812 00000 n
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Topline Phase 3 Data. 0000001656 00000 n
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Positive results from a phase III study of omidubicel, a cell therapy product of expanded umbilical cord blood (UCB) cells, (NCT02730299) have been announced.1 The study investigated the safety and efficacy of omidubicel, compared to standard UCB transplant, in patients with high-risk hematological malignancies without a suitable matched donor. 0000332800 00000 n
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