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Miltenyi Biotec obtains FDA approval for CliniMACS CD34 reagent system

German biotechnology company Miltenyi Biotec has received the US Food and Drug Administration’s (FDA) approval for its CliniMACS CD34 reagent system to prevent graft-versus-host disease (GVHD) in the treatment of acute myeloid leukemia (AML).

The FDA approval of the CD34 reagent system as a humanitarian use device for the GVHD is based on data from Phase II clinical study conducted by the Blood and Marrow Transplant Clinical Trials Network.

This study 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% at two years after transplantation) without negatively affecting relapse, engraftment, overall survival or disease-free survival.

The National Heart, Lung, and Blood Institute and the National Cancer Institute of The National Institutes of Health have supported the single-arm, multi-center study (BMT CTN 0303).

Miltenyi Biotec’s CliniMACS CD34 reagent system 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 device decreases the risk of developing GVHD, a life-threatening complication that can occur following an allogeneic transplant, in which T cells from the donor attack various tissues of the recipient.

The company claims that the CD34 reagent system efficiently removes donor T cells from the graft prior to transplantation by enriching CD34+ blood stem cells, which go on to repopulate the patient’s immune and blood building systems.

Miltenyi Biotec president and founder of Stefan Miltenyi noted when chronic GVHD develops after stem cell transplantation, the result is a substantial decrease in the patient’s quality of life.

"We are very excited to be able to provide a new treatment option to clinicians and their patients having to undergo a transplantation procedure. Miltenyi added.