By Catherine Eckford – European Pharmaceutical Review
The first allogeneic stem cell transplant therapy to be approved based on Phase III study results has been granted by the US Food and Drug Administration (FDA).
Allogeneic hematopoietic stem cell transplantation offers a potentially curative option for haematologic malignancies including acute myeloid leukaemia, acute lymphoblastic leukaemia, chronic myeloid leukaemia and myelodysplastic syndromes. This type of transplant uses cells from a donor other than the recipient.
Omisirge is a nicotinamide modified allogeneic cell therapy derived from cord blood. It is manufactured to enhance and expand the number of progenitor cells utilising proprietary nicotinamide (NAM) technology.
This process produces enriched hematopoietic progenitor cells. Thus it can help preserve their stemness, homing to the bone marrow and retained engraftment capacity, according to developer of the treatment, Gamida Cell.