{"entity":{"id":"omidubicel","kind":"drug","name":"Omidubicel","aka":[],"tldr":"An expanded umbilical cord blood graft that shortens the dangerous wait for neutrophils to return after a transplant for blood cancer, the first cell therapy approved to speed engraftment.","summary":"Omidubicel takes a single umbilical cord blood unit and expands its stem and progenitor cells for three weeks with nicotinamide, so that patients with blood cancers who need a cord blood transplant but lack a matched donor receive a larger graft. In its phase 3 trial against standard cord blood transplantation, neutrophil recovery came sooner and serious bacterial and fungal infections were fewer. The FDA approved it in April 2023 for adults and children aged 12 and over with haematologic malignancies planned for cord blood transplantation after myeloablative conditioning. It is manufactured for each patient from a matched cord blood unit.","status":"approved","asOf":"2026-09-04","links":[{"label":"FDA approval announcement (April 2023)","url":"https://www.fda.gov/news-events/press-announcements/fda-approves-cell-therapy-patients-blood-cancers-reduce-risk-infection-following-stem-cell"}],"tags":[],"related":[],"cancers":["aml","all-leukemia","mds"],"sections":["cell-therapy"],"technologies":["allogeneic-hsct"],"targets":[],"drugs":[],"companies":["gamida-cell"],"institutions":[],"pathways":[],"terms":[],"trials":["nct02730299"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Omisirge","modality":"Nicotinamide-expanded allogeneic cord blood cell therapy","mechanism":"Ex vivo nicotinamide-based expansion of CD34-positive cord blood cells preserves stemness while multiplying the graft, so engraftment after myeloablative conditioning is faster.","approvals":[{"region":"US","year":2023,"indication":"Adults and children aged 12 and over with haematologic malignancies undergoing umbilical cord blood transplantation after myeloablative conditioning, to reduce time to neutrophil recovery and infection"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/omidubicel/","neighbours":{"cancer":[{"id":"all-leukemia","kind":"cancer","name":"Acute lymphoblastic leukaemia","route":"/cancers/all-leukemia/"},{"id":"aml","kind":"cancer","name":"Acute myeloid leukaemia","route":"/cancers/aml/"},{"id":"mds","kind":"cancer","name":"Myelodysplastic syndromes / neoplasms (MDS)","route":"/cancers/mds/"}],"section":[{"id":"cell-therapy","kind":"section","name":"Cell Therapy","route":"/fronts/cell-therapy/"}],"technology":[{"id":"allogeneic-hsct","kind":"technology","name":"Allogeneic stem cell transplantation","route":"/technologies/allogeneic-hsct/"}],"company":[{"id":"gamida-cell","kind":"company","name":"Gamida Cell","route":"/companies/gamida-cell/"}],"trial":[{"id":"nct02730299","kind":"trial","name":"Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS","route":"/trials/nct02730299/"}]}}