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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.
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.
Ex vivo nicotinamide-based expansion of CD34-positive cord blood cells preserves stemness while multiplying the graft, so engraftment after myeloablative conditioning is faster.
1.Omidubicel slips into a pocket on its target.
| Region | Year | Indication |
|---|---|---|
| US | 2023 | 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 |
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Query for this drug: (TITLE:"Omidubicel" OR ABSTRACT:"Omidubicel" OR TITLE:"Omisirge" OR ABSTRACT:"Omisirge") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Omidubicel, not a curated reading list.
Shares Myelodysplastic syndromes / neoplasms (MDS), Acute lymphoblastic leukaemia, Acute myeloid leukaemia.
Shares Allogeneic stem cell transplantation, Myelodysplastic syndromes / neoplasms (MDS), Acute lymphoblastic leukaemia, Acute myeloid leukaemia.
Shares Allogeneic stem cell transplantation, Myelodysplastic syndromes / neoplasms (MDS), Acute lymphoblastic leukaemia, Acute myeloid leukaemia.
Shares Myelodysplastic syndromes / neoplasms (MDS), Acute lymphoblastic leukaemia, Acute myeloid leukaemia.
Shares Myelodysplastic syndromes / neoplasms (MDS), Acute lymphoblastic leukaemia, Acute myeloid leukaemia.
Shares Allogeneic stem cell transplantation, Acute lymphoblastic leukaemia, Acute myeloid leukaemia.
Shares Myelodysplastic syndromes / neoplasms (MDS), Acute lymphoblastic leukaemia, Acute myeloid leukaemia.
Shares Myelodysplastic syndromes / neoplasms (MDS), Acute lymphoblastic leukaemia, Acute myeloid leukaemia.