FDA approves CliniMACS System for GVH Disease-Miltenyi Biotec

The FDA has approved the CliniMACS CD34 Reagent System, from Miltenyi Biotec, as a Humanitarian Use Device for the prevention of Graft-Versus-Host Disease (GVHD) in patients with Acute Myeloid Leukemia (AML) in first complete remission undergoing allogeneic stem cell transplantation (SCT) from a matched related donor. The CliniMACS CD34 Reagent System is an in vitro medical device system that uses antibodies conjugated to magnetic beads to select and enrich for CD34+ blood stem cells from a donor graft prior to transplantation, while removing other cells that can cause GVHD.

The FDA approval was based on data from a Phase II, single-arm, multi-center study (BMT CTN 0303) conducted by the Blood and Marrow Transplant Clinical Trials Network which is supported by The National Heart, Lung, and Blood Institute and The National Cancer Institute of The National Institutes of Health. The trial showed that following intensive myeloablative conditioning, stem cell transplantation from an identical sibling donor processed using the CliniMACS CD34 Reagent System as the sole means of GVHD prophylaxis leads to a low incidence of chronic GVHD (19 percent at two years after transplantation) without negatively affecting relapse, engraftment, overall survival or disease-free survival.