The U.S. Food and Drug Administration (FDA) has given the green light to a new treatment called Omidubicel-onlv. This treatment is designed for patients who are 12 years or older and have blood cancers. They are typically about to receive an umbilical cord blood transplant following a specific process that clears out their bone marrow.

Omidubicel-onlv is a special type of treatment made from umbilical cord blood that’s been tweaked in the lab to speed up the recovery of a type of white blood cell called neutrophils. These cells are a crucial part of our immune system, helping fight off infections. By speeding up their recovery, this treatment aims to lower the risk of infection in these patients.

Here’s how the approval came about: The FDA looked at the results from a study that compared regular umbilical cord blood transplants to transplants with Omidubicel-onlv. In this study, 87% of the patients who got Omidubicel-onlv saw their neutrophil levels bounce back in about 12 days. Compare that to 83% of patients who got regular cord blood transplants, where it took about 22 days on average for their neutrophil levels to rebound. So, the Omidubicel-onlv treatment seems to speed things up.

Like with most treatments, there can be side effects. Patients who got this treatment experienced things like graft-versus-host-disease (this is when the new cells attack the patient’s body), reactions to the infusion, and infections. There’s also a warning about engraftment syndrome and graft failure – in simpler terms, these are complications where the new cells either cause a severe inflammatory response or don’t settle into the bone marrow to start producing new blood cells.

The approval of this treatment is considered a significant step forward. As the director of the FDA’s Center for Biologics Evaluation and Research noted, speeding up the return of white blood cells in the body can lower the risk of severe or overwhelming infections that can happen after a stem cell transplant.