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An investigational cell therapy consisting of ex vivo expanded umbilical cord blood (UCB)-derived regulatory T cells (Tregs) developed by the Masonic Cancer Center at the University of Minnesota. The therapy is specifically designed for the prevention of acute graft-versus-host disease (aGVHD) in adult patients undergoing double umbilical cord blood transplantation for hematologic malignancies. The active component consists of CD4+CD25+FoxP3+ regulatory T cells that are enriched from cryopreserved UCB and expanded using either anti-CD3/anti-CD28 antibody-coated beads and recombinant human interleukin-2 (IL-2) or K562 cells modified to express CD64 and CD86 (KT64/86). These Tregs function by suppressing the expansion and activation of CD8+ effector T cells in GVHD target organs, thereby reducing the incidence of grade II-IV acute GVHD without compromising the graft-versus-leukemia effect.
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