Miltenyi Biotec has obtained approval from the US Food and Drug Administration (FDA) for its CliniMACS CD34 reagent system for prevention of graft-versus-host disease (GVHD) in the treatment of acute myeloid leukemia (AML).
The FDA has approved the CD34 in-vitro reagent system as a humanitarian-use device for GVHD in patients with AML in first complete remission undergoing allogeneic stem cell transplantation (SCT) from a matched related donor.
Approval is based on FDA’s review of data from a Phase II clinical study conducted by the Blood and Marrow Transplant Clinical Trials Network.
The study demonstrated 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-centre study (BMT CTN 0303).
By using antibodies conjugated to magnetic beads, the CliniMACS CD34 reagent system is designed to select and enrich CD34+ blood stem cells from a donor graft prior to transplantation and removes other cells that can cause GVHD.
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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 said: "We are very excited to be able to provide a new treatment option to clinicians and their patients having to undergo a transplantation procedure."
GVHD is a life-threatening complication that can occur following an allogeneic transplant, where T cells from the donor attack various tissues of the recipient.
Image: Three phases of GVHD immuno-biology. Photo: courtesy of Smallbot.