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Phase I Trial of ex-vivo Expanded Donor Regulatory T Cells for Prevention of Acute Graft-Versus-Host Disease
Clinical trial of allospecific regulatory t cells (Tregs) for prevention of acute graft-versus-host disease (GVHD) in human leukocyte antigen (HLA) identical sibling transplants.
The primary objective of this trial is to evaluate the safety of sirolimus based immune suppression and ex-vivo expanded donor regulatory T cells for the prevention of acute graft-versus-host disease following allogeneic hematopoietic cell transplantation. Secondary objectives will monitor Treg repopulation, longevity, and antigen-specific suppressive function after HCT in vivo.
FK506 (Tacrolimus); Rapamune (Sirolimus); Rapamycin (Sirolimus); Sirolimus (); Tacrolimus ()