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Omidubicel (Omisirge) is an FDA-approved, allogeneic hematopoietic stem cell therapy developed by Gamida Cell. It consists of ex vivo expanded hematopoietic progenitor cells derived from a single umbilical cord blood (UCB) unit. The manufacturing process utilizes nicotinamide (NAM) technology to inhibit the differentiation and enhance the homing and engraftment potential of CD133+ cells. The product is composed of two fractions: an expanded CD133+ cell fraction and a non-expanded CD133- fraction containing myeloid and lymphoid cells. It is primarily indicated for adult and pediatric patients with hematologic malignancies undergoing umbilical cord blood transplantation to accelerate neutrophil recovery and reduce the risk of infection. Clinical studies have also demonstrated its potential in non-malignant bone marrow failure syndromes, including sickle cell disease and severe aplastic anemia.
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