Drug intelligence / Profile preview

omidubicel + omidubicel non-cultured fraction

Development stage
Approved
Lead developer
Gamida Cell
Modality
Stem Cell Therapies → Cell Therapies
Administration
Intravenous
01

Overview

Omidubicel + omidubicel non-cultured fraction is a **two-fraction allogeneic cord blood-derived hematopoietic progenitor cell therapy** corresponding to the full omidubicel graft product. It consists of an ex vivo nicotinamide-expanded cultured fraction enriched for CD34-positive hematopoietic progenitor cells and a separately infused non-cultured fraction containing CD3-positive immune cells derived from the same umbilical cord blood unit. The product was developed by Gamida Cell and marketed as Omisirge for use in patients aged 12 years and older with hematologic malignancies undergoing umbilical cord blood transplantation following myeloablative conditioning, with the therapeutic goal of accelerating neutrophil recovery and reducing early post-transplant infections. Mechanistically, nicotinamide-based ex vivo culture is used to inhibit differentiation and preserve or enhance the functional capacity of hematopoietic stem and progenitor cells, while the non-cultured fraction complements engraftment with immune cell content required for the complete transplant product.

Other names
omidubicel + omidubicel non-cultured fractionomidubicel cultured fraction + omidubicel non-cultured fraction

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