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Positive results from a phase III study of omidubicel, a cell therapy product of expanded umbilical cord blood (UCB) cells, (NCT02730299) have been announced.1 The study investigated the safety and efficacy of omidubicel, compared to standard UCB transplant, in patients with high-risk hematological malignancies without a suitable matched donor.2
Top-line results from the study demonstrated that treatment with omidubicel significantly reduced the median time to neutrophil engraftment by 10 days compared to standard UCB transplant (p < 0.001) and was generally well tolerated. Furthermore, a greater percentage of patients achieved successful neutrophil engraftment compared with patients in the comparator group (96% vs 88%, respectively).1
Full efficacy and safety results are expected to be presented later this year, and a biologics license application is due to be submitted to the FDA by the end of the year.
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