Key points from article :
The U.S. Food and Drug Administration (FDA) has approved Omisirge® (omidubicel-onlv), marking the first allogeneic stem cell transplant therapy to gain approval based on Phase III clinical trial results. This treatment is designed for patients aged 12 and older with blood cancers undergoing umbilical cord blood transplantation, aiming to speed up immune recovery and reduce infection risks.
Omisirge is an advanced form of allogeneic stem cell therapy, derived from umbilical cord blood and enhanced using proprietary nicotinamide (NAM) technology. This process helps maintain the cells’ ability to migrate to the bone marrow and support long-term engraftment. In clinical trials, Omisirge reduced the median time to immune cell recovery to 12 days, compared to 22 days with standard cord blood transplants, and lowered infection rates.
Beyond its medical benefits, Omisirge could expand transplant options for racially and ethnically diverse patients, who often struggle to find fully matched donors. Black or African American patients, for example, have only a 29% chance of finding a match in donor registries, compared to 79% for White patients. By providing an alternative donor source, Omisirge could improve access to life-saving transplants for underrepresented groups.
