FDA OKs stem cell therapy to reduce infection risk in blood cancer patients
was based on phase 3 testing that pitted the use of omidubicel in 62 patients against standard unmanipulated cord blood transplants in 63 patients following myeloablative conditioning.
The incidence of grade 2/3 bacterial or grade 3 fungal infections 100 days following transplant was 39% with omidubicel, vs 60% with standard transplants. The most common grade 3–5 adverse reactions in the approval study were pain , mucosal inflammation , hypertension , and gastrointestinal toxicity .
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