FDAnews Device Daily Bulletin

FDA Approves Graft-vs.-Host Disease Prevention System for Humanitarian Use

Jan. 27, 2014

Miltenyi Biotec said Friday that the FDA has green-lighted its CliniMACS CD34 Reagent System for use in preventing graft-versus-host disease in patients in first complete remission from acute myeloid leukemia who are undergoing an allogeneic stem cell transplant from a matched related donor.

The device was approved via the humanitarian device exemption pathway, based on data from a Phase II single-arm, multicenter study that showed only a 19 percent incidence of GVHD two years post-transplant in patients who received stem cells from a sibling donor with matching tissue type processed with the system.

Miltenyi is in discussions with the FDA about a Phase III trial and hopes to have it underway within the year. The Phase III study, which is intended to support full premarket approval, will evaluate the system beyond indications for acute leukemia and include unrelated donors, said company spokeswoman Tara Clark.

The CliniMACS CD34 Reagent System removes donor T cells from the graft prior to transplant by enriching CD34 blood stem cells, using antibodies conjugated to magnetic beads, according to the company. The enriched stem cells go on to repopulate the patient’s immune and blood-building systems, the company said. — Lena Freund

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