FDA approves cord-blood therapy

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The US Food and Drug Administration has approved an umbilical cord blood-based therapy for blood-cancer patients requiring a stem cell transplant. Gamida Cell’s Omisirge (omidubicel) is an allogeneic source of hematopoietic stem cells for transplant, particularly in cases where patients have no matched adult bone marrow donors nor peripheral blood-derived stem cells. Gamida Cell uses nicotinamide — vitamin B3 — to expand umbilical cord blood cells in vitro. Nicotinamide upregulates transcription factors important for stem cell renewal and DNA repair and downregulates those that activate cell differentiation. The lab-expanded allogeneic cells have better marrow homing and engraftment potential, resulting in faster hematopoietic recovery, lower risk of infection and overall better clinical outcomes than with current treatments.

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FDA approves cord-blood therapy.
Nat Biotechnol 41, 589 (2023). https://doi.org/10.1038/s41587-023-01808-6

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  • DOI: https://doi.org/10.1038/s41587-023-01808-6

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