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The CD34+ cell enriched stem cell graft is an allogeneic cell therapy product developed by the University of Florida for the treatment of various hematologic and immunologic disorders. The graft is prepared from donor peripheral blood stem cells (PBSCs) using the Miltenyi CliniMACS Prodigy system, which performs automated ex vivo selection of CD34+ hematopoietic stem and progenitor cells. This process effectively enriches the stem cell population while depleting T-cells, thereby reducing the risk of graft-versus-host disease (GVHD) in the recipient. This T-cell depletion strategy allows for safer allogeneic transplantation in patients with non-malignant conditions such as severe combined immunodeficiency (SCID), Fanconi anemia, dyskeratosis congenita, and sickle cell disease, as well as in cases of poor graft function or graft failure. The University of Florida provides this manipulated graft under an expanded access protocol (NCT04304391) for patients who lack other suitable treatment options.
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