Omisirge is administered through a single intravenous dose and contains human allogeneic stem cells from umbilical cord blood that is processed and cultured. The product is designed for patients 12 years and older with blood cancers planned for umbilical cord blood transplantation following a myeloablative conditioning regimen, according to an April 17 FDA release.
Omisirge is modified to enable faster recovery of neutrophils compared with umbilical cord blood transplantation, which reduces risk of infection.
In a trial of 125 subjects with blood cancer, Omisirge helped 87 percent of patients achieve neutrophil recovery in a median of 12 days, compared with 83 percent for patients who received umbilical cord blood transplantation and achieved recovery with a median of 22 days. Infection by 100 days following transplantation was 39 percent for those with Omisirge and 60 percent for those in the control group.
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