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darTreg refers to autologous donor-alloantigen–reactive regulatory T cells (Tregs) that are expanded ex vivo and infused into transplant recipients. These cells are a form of adoptive cell therapy designed to induce immune tolerance specifically toward the transplanted organ by suppressing alloreactive immune responses while sparing general immunity. The mechanism involves isolating recipient-derived CD4+CD25hiFoxp3+ regulatory T cells that are selectively reactive to donor antigens, expanding them in vitro, and then infusing them back into the patient post-transplantation. The primary indication is for promoting immunological tolerance in solid organ transplantation (notably liver and kidney), with the goal of reducing or eliminating the need for long-term systemic immunosuppression. Clinical studies have shown safety but also highlighted challenges such as loss of function or phenotype after infusion[2][3][4][5].
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