Harden, Paul N. and Game, David S. and Sawitzki, Birgit and van der Net, Jeroen B. and Hester, Joanna and Bushell, Andrew and Issa, Fadi and Brook, Matthew O. and Alzhrani, Alaa and Schlickeiser, Stephan and Scotta, Cristiano and Petchey, William and Streitz, Mathias and Blancho, Gilles and Tang, Quizhi and Markmann, James and Lechler, Robert I. and Roberts, Ian S. D. and Friend, Peter J. and Hilton, Rachel and Geissler, Edward K. and Wood, Kathryn J. and Lombardi, Giovanna (2021) Feasibility, long-term safety, and immune monitoring of regulatory T cell therapy in living donor kidney transplant recipients. AMERICAN JOURNAL OF TRANSPLANTATION, 21 (4). pp. 1603-1611. ISSN 1600-6135, 1600-6143
Full text not available from this repository. (Request a copy)Abstract
Short-term outcomes in kidney transplantation are marred by progressive transplant failure and mortality secondary to immunosuppression toxicity. Immune modulation with autologous polyclonal regulatory T cell (Treg) therapy may facilitate immunosuppression reduction promoting better long-term clinical outcomes. In a Phase I clinical trial, 12 kidney transplant recipients received 1-10 x 10(6) Treg per kg at Day +5 posttransplantation in lieu of induction immunosuppression (Treg Therapy cohort). Nineteen patients received standard immunosuppression (Reference cohort). Primary outcomes were rejection-free and patient survival. Patient and transplant survival was 100%; acute rejection-free survival was 100% in the Treg Therapy versus 78.9% in the reference cohort at 48 months posttransplant. Treg therapy revealed no excess safety concerns. Four patients in the Treg Therapy cohort had mycophenolate mofetil withdrawn successfully and remain on tacrolimus monotherapy. Treg infusion resulted in a long-lasting dose-dependent increase in peripheral blood Tregs together with an increase in marginal zone B cell numbers. We identified a pretransplantation immune phenotype suggesting a high risk of unsuccessful ex-vivo Treg expansion. Autologous Treg therapy is feasible, safe, and is potentially associated with a lower rejection rate than standard immunosuppression. Treg therapy may provide an exciting opportunity to minimize immunosuppression therapy and improve long-term outcomes.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | ; clinical research/practice; clinical trial; immune regulation; immunosuppression/ immune modulation; immunosuppressive regimens; minimization/withdrawal; kidney transplantation/nephrology; kidney transplantation: living donor; monitoring: immune; translational research/science |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Chirurgie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 21 Sep 2022 07:10 |
| Last Modified: | 21 Sep 2022 07:10 |
| URI: | https://pred.uni-regensburg.de/id/eprint/47789 |
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