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Regulatory T-cell enriched infusion is a cell therapy modality that involves the administration of donor-derived regulatory T cells (Tregs) to modulate the recipient's immune response, particularly in the setting of allogeneic hematopoietic stem cell transplantation (HSCT). The therapy aims to prevent or treat graft-versus-host disease (GVHD) by utilizing the natural immunosuppressive properties of Tregs (typically defined as CD4+CD25+Foxp3+ cells) to inhibit the activation and proliferation of alloreactive effector T cells. This approach is designed to reduce the incidence of severe GVHD while maintaining the beneficial graft-versus-leukemia (GVL) effect. Various manufacturing techniques, including high-precision single-cell sorting, are employed to create these enriched cell products. Clinical development is being conducted by academic institutions such as the Dana-Farber Cancer Institute and the Fundación Pública Andaluza para la Gestión de la Investigación, as well as commercial entities like Orca Bio, which is developing specific formulations such as Orca-T (TRGFT-201).
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