Moreau, Aurelie and Kervella, Delphine and Bouchet-Delbos, Laurence and Braudeau, Cecile and Saiagh, Soraya and Guerif, Pierrick and Limou, Sophie and Moreau, Anne and Bercegeay, Sylvain and Streitz, Mathias and Sawitzki, Birgit and James, Ben and Harden, Paul N. and Game, David and Tang, Qizhi and Markmann, James F. and Roberts, Ian S. D. and Geissler, Edward K. and Dreno, Brigitte and Josien, Regis and Cuturi, Maria-Cristina and Blancho, Gilles (2023) A Phase I/IIa study of autologous tolerogenic dendritic cells immunotherapy in kidney transplant recipients. KIDNEY INTERNATIONAL, 103 (3). pp. 627-637. ISSN 0085-2538, 1523-1755
Full text not available from this repository. (Request a copy)Abstract
Kidney transplant survival is shortened by chronic rejection and side effects of standard immunosuppressive drugs. Cell based immunotherapy with tolerogenic dendritic cells has long been recognized as a promising approach to reduce general immunosuppression. Published trials report the safety and the absence of therapy-related adverse reactions in patients treated with tolerogenic dendritic cells suffering from several inflammatory diseases. Here, we present the first phase I clinical trial results using human autologous tolerogenic dendritic cells (ATDC) in kidney transplantation. Eight patients received ATDC the day before transplantation in conjunction with standard steroids, mycophenolate mofetil and tacrolimus immunosuppression with an option to taper mycophenolate mofetil. ATDC preparations were manufactured in a Good Manufacturing Practice-compliant facility and fulfilled cell count, viability, purity and identity criteria for release. A control group of nine patients received the same standard immunosuppression, except basiliximab induction replaced ATDC therapy and mycophenolate tapering was not allowed. During the three-year follow-up, no deaths occurred and there was 100% graft survival. No significant increase of adverse events was associated with ATDC infusion. Episodes of rejection were observed in two patients from the ATDC group and one patient from the control group. However, all rejections were successfully treated by glucocorticoids. Mycophenolate was successfully reduced/stopped in five patients from the ATDC group, allowing tacrolimus monotherapy for two of them. Regarding immune monitoring, reduced CD8 T cell activation markers and increased Foxp3 expression were observed in the ATDC group. Thus, our results demonstrate ATDC administration safety in kidney-transplant recipients.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | PROLONG ALLOGRAFT SURVIVAL; REGULATORY T-CELLS; ANTIGEN; ALEMTUZUMAB; TACROLIMUS; THERAPY; SAFETY; cell therapy; clinical trial; dendritic cells; tolerance; transplantation |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Chirurgie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 30 Jan 2024 10:34 |
| Last Modified: | 30 Jan 2024 10:34 |
| URI: | https://pred.uni-regensburg.de/id/eprint/60788 |
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