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Feasibility, long-term safety, and immune monitoring of regulatory T cell therapy in living donor kidney transplant recipients
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International audience. Short-term outcomes in kidney transplantation are marred by progressive transplantfailure and mortality secondary to immunosuppression toxicity. Immune modulationwith autologous polyclonal regulatory T cell (Treg) therapy may facilitate immunosup-pression reduction promoting better long-term clinical outcomes. In a Phase I clini-cal trial, 12 kidney transplant recipients received 1–10 × 106 Treg per kg at Day +5posttransplantation in lieu of induction immunosuppression (Treg Therapy cohort).Nineteen patients received standard immunosuppression (Reference cohort). Primaryoutcomes were rejection-free and patient survival. Patient and transplant survival was100%; acute rejection-free survival was 100% in the Treg Therapy versus 78.9% in thereference cohort at 48 months posttransplant. Treg therapy revealed no excess safetyconcerns. Four patients in the Treg Therapy cohort had mycophenolate mofetil with -drawn successfully and remain on tacrolimus monotherapy. Treg infusion resulted ina long-lasting dose-dependent increase in peripheral blood Tregs together with anincrease in marginal zone B cell numbers. We identified a pretransplantation immunephenotype suggesting a high risk of unsuccessful ex-vivo Treg expansion. AutologousTreg therapy is feasible, safe, and is potentially associated with a lower rejection ratethan standard immunosuppression. Treg therapy may provide an exciting opportunityto minimize immunosuppression therapy and improve long-term outcomes
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