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Omidubicel is a nicotinamide-modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for use in patients with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning.
Omidubicel is a nicotinamide-modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for use in patients with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning.
Omidubicel is a cryopreserved nicotinamide-modified allogeneic hematopoietic progenitor cell therapy manufactured from patient-specific umbilical cord blood (UCB) and processed in a way that enhances the functionality of hematopoietic progenitor cells (HPCs). A single banked UCB unit is separated into 2 cell fractions by CD133 selection, forming a CD133+ or cultured fraction (CF) and a CD133− or non-cultured fraction (NF). The CD133+ or CF is expanded using nicotinamide, a small molecule that inhibits differentiation, increases the frequency of CD34+ HPCs and decreases the frequency of lineage-committed progenitor cells. The use of nicotinamide overcomes the induction of accelerated proliferation, differentiation, cellular stress and signaling pathways that are typically activated when HPCs are removed from their natural environment. This allows HPCs derived from UCB and cultured ex-vivo to preserve their stemness, increasing their capacity for bone marrow migration, rapid engraftment and multi-lineage immune reconstitution. The use of this cell therapy is beneficial in patients with hematologic malignancies that do not have HLA-matched related donors, as it allows them to restore their ability to produce blood and immune cells.
Omidubicel is indicated for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.
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