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Expanded regulatory T cells (Tregs) are a type of adoptive cell therapy where CD4+CD25+FOXP3+ regulatory T cells are isolated from a patient's peripheral blood, expanded ex vivo under specific conditions, and then reinfused to modulate immune responses. Tregs naturally function to maintain immune homeostasis, prevent autoimmunity, and suppress excessive immune responses. The manufacturing process typically involves: 1. Isolation of CD4+CD25+CD127lo/- T cells from peripheral blood 2. Expansion through stimulation with anti-CD3/CD28 beads or antigen-presenting cells 3. Culture with IL-2 and often rapamycin to maintain Treg phenotype and function 4. Quality control to ensure purity and suppressive function 5. Reinfusion into patients Expanded Tregs can be polyclonal (non-specific) or antigen-specific (such as alloantigen-reactive Tregs or darTregs). They function through multiple mechanisms including cytokine deprivation, direct cell contact, and modulation of antigen-presenting cells. ## Clinical Applications Expanded regulatory T cells are being investigated in clinical trials for: 1. **Autoimmune diseases**: Type 1 diabetes, lupus, pemphigus 2. **Transplantation**: Prevention of graft rejection in solid organ transplants (kidney, liver) 3. **Graft-versus-host disease (GvHD)**: Prevention and treatment after hematopoietic stem cell transplantation Clinical trials have demonstrated safety and promising efficacy, with some studies showing that Treg therapy can allow reduction of conventional immunosuppressive medications in transplant recipients.
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