Cell Separation System for Fully Automated Clinical Scale Separation ...
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Cell Separation System for Fully Automated Clinical Scale Separation ...
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with [18F]FHBG, we detected CD34-TK75+ human T cells in the thymus and lymph nodes only in mice that developed GvHD. Summary: This "first-in-man" study demonstrated the safety and feasibility of manufacturing both CD34-TK75+ T cells and [18F]FHBG onsite for administration to patients. A future upfront haploidentical transplant study will employ 100-fold more CD34-TK75 modified T cells.
176 Cell Separation System for Fully Automated Clinical Scale Separation of CD34+ Cells from Leukapheresis Products Mike Essl, Juliane Stuth, Kristina Reck, Volker Huppert, Nanette von Oppen, Dirk Balshüsemann, Gerd Steffens, Juergen Schmitz. Miltenyi Biotec GmbH, Bergisch Gladbach, Germany In vitro CD34 enrichment of stem cell grafts is widely used for depleting T cells from the graft. A high ex vivoT cell depletion enables effective prevention of Graft-Versus Host Disease (GVHD) e a major complication after allogeneic stem cell transplantation. Until now, the clinical scale enrichment of CD34 positive cells is a complex procedure involving numerous manual steps. We have developed a fully automated clinical scale process within a closed sterile system to purify CD34+cells from human leukapheresis products. In this context, cell washing, erythrocyte reduction, cell labeling and the conditions for immunomagnetic separation were optimized. To determine the process performance, CD34+cells were separated from human leukapheresis products with an initial volume of 120 mL to 211 mL (n¼5). We performed colonyforming unit (CFU) assays, which allowed us to evaluate the differentiation potential of the enriched cells. The total processing time was 99.9%. CFU assays performed after the fully automated enrichment process showed that the CD34+cell fraction contained primitive and multipotent progenitor cells, such as CFU-GEMM and CFU-GM. The cell separation system described provides a safe and easy way to purify CD34+ cells from leukapheresis within
