Omidubicel Can ‘Improve Outcomes’ in Blood Cancer Needing UCB Transplant

Corey Cutler, MD, MPH, FRCPC, discusses how patients with blood cancer in need of an umbilical cord blood transplant may benefit from omidubicel-onlv.

Following the FDA approval of omidubicel-onlv (Omisirge) for hematologic cancer requiring an umbilical cord blood transplant, Corey S. Cutler, MD, MPH, FRCPC, stated that the next step is to compare the agent with haploidentical transplantation.

Cutler indicated that haploidentical transplant has the potential to perform better, be cheaper, and be easier to implement. As such, it’s necessary to compare the strategy vs omidubicel.

Omidubicel, which was recently approved by the FDA, is the first substantially modified allogeneic cord blood–based cell therapy for patients who are 12 years or older with a hematologic malignancy requiring an allogeneic hematopoietic stem cell transplant after a myeloablative conditioning regimen.1 Supporting results came from a phase 3 trial (NCT02730299) assessing the efficacy and safety of omidubicel vs standard cord blood transplant.2

Study author Cutler, director of Clinical Research, Stem Cell Transplantation; director of the Stem Cell Transplantation Survivorship Program; and an institute physician at Dana-Farber Cancer Institute, as well as an associate professor of Medicine at Harvard Medical School, spoke with CancerNetwork® prior to the approval about omidubicel’s potential impact after cord blood transplant has become less favored.


We are not sure omidubicel will be incorporated into clinical practice. Umbilical cord blood transplant, in recent years, has largely fallen out of favor with the advent and broad applicability of haploidentical transplantation. There is still a subset of patients who require umbilical cord blood as their only source of donor stem cells. For these [patients], omidubicel will certainly improve their outcomes.

Moving forward, what will need to be done would be a proper comparison between omidubicel and haploidentical transplants. Prior comparisons of standard umbilical cord transplant and haploidentical transplantation have suggested that haploidentical transplantation might be slightly more efficacious, certainly less expensive, and logistically a little bit easier. We don’t know how that equation tilts when omidubicel is on the market.


  1. FDA approves cell therapy for patients with blood cancers to reduce risk of infection following stem cell transplantation. News release. FDA. April 17, 2023. Accessed April 17, 2023.
  2. Horwitz ME, Stiff PJ, Cutler C, et al. Omidubicel vs standard myeloablative umbilical cord blood transplantation: results of a phase 3 randomized study. Blood. 2021;138(16):1429-1440. doi:10.1182/blood.2021011719
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