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Elutriated CD34+ augmented donor bone marrow is an investigational cellular therapy product prepared through ex vivo physical manipulation of allogeneic bone marrow. The manufacturing process utilizes counterflow centrifugal elutriation (CCE) to separate bone marrow cells into distinct fractions based on size and density. The primary objective is to achieve substantial depletion of T-lymphocytes, which typically reside in the smaller-cell fractions, thereby reducing the incidence and severity of Graft-versus-Host Disease (GvHD). Because extensive T-cell depletion can lead to delayed engraftment or graft failure, the protocol involves the isolation of CD34+ hematopoietic progenitor cells from the otherwise discarded elutriated small-cell fractions. These CD34+ cells are then added back ("augmented") to the large-cell fraction containing the bulk of the hematopoietic precursors. This engineered graft aim to provide the safety profile of a T-cell depleted transplant while maintaining the rapid and robust hematopoietic reconstitution characteristic of unmanipulated marrow. This protocol was primarily developed and evaluated by researchers at Johns Hopkins University for use in high-risk hematologic malignancies and as a supportive rescue therapy in high-dose chemotherapy regimens for breast cancer.
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