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Donor-derived regulatory T cell (Treg) therapy is an adoptive cellular immunotherapy developed by the Instituto de Medicina Molecular João Lobo Antunes (iMM) for the treatment of steroid-refractory chronic graft-versus-host disease (cGVHD). The therapy involves the isolation of CD4+CD25+ regulatory T cells from an allogeneic donor using CliniMACS selection technology. These cells are administered as a fresh infusion to patients who have undergone allogeneic hematopoietic stem cell transplantation (HSCT) and subsequently developed cGVHD. The primary mechanism of action is the suppression of alloreactive conventional T cell responses, which helps to control the immune-mediated tissue damage characteristic of GVHD while potentially preserving the beneficial graft-versus-leukemia effect. This treatment is being evaluated in Phase I/II clinical trials as part of the TREGeneration consortium, a collaborative European initiative.
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