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This is an engineered allogeneic peripheral blood stem cell (PBSC) graft product developed by the Fred Hutchinson Cancer Center for the prevention of graft-versus-host disease (GVHD) in patients undergoing hematopoietic cell transplantation. The manufacturing process involves a two-step immunomagnetic selection using the CliniMACS system: first, CD34+ hematopoietic stem cells are positively selected to ensure robust engraftment, and second, CD45RA+ naïve T cells are selectively depleted. By removing naïve T cells—which are the primary drivers of GVHD—while retaining memory T cells, the graft provides rapid immune reconstitution and maintains anti-pathogen and anti-leukemia activity with a significantly reduced risk of chronic GVHD. This cell therapy modality was developed by Dr. Marie Bleakley and has been primarily evaluated in patients with acute leukemia or myelodysplastic syndrome (MDS).
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