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Kidney transplant: Novel cell therapy successfully used in a clinical trial for the first time

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(Vienna, 18 June 2026) Cell therapies, such as the administration of so-called regulatory T cells, are regarded as a beacon of hope for the future of transplant medicine, as they can suppress patients’ immune responses against the transplanted organ. However, previous studies with regulatory T cells have shown only moderate efficacy. A research team at MedUni Vienna has now, for the first time, combined the administration of regulatory T cells with a second cell therapy and additionally administered bone marrow cells from the kidney donor. The results of this study, currently published in the journal "Science Translational Medicine", provide promising evidence of the positive effect of this therapeutic approach for better control of the immune response following kidney transplantation.

Improved, targeted inhibition of the immune response against the transplanted kidney could further improve long-term outcomes following transplantation. The administration of donor bone marrow cells in addition to the donor kidney can lead to such positive immune modulation in transplant recipients. Through many years of preclinical research, the team led by Thomas Wekerle (Division of Transplantation, Department of General Surgery, MedUni Vienna) has developed a treatment protocol that is particularly low in side effects and, unlike all previous approaches, does not require patients to undergo radiation therapy. This goal was achieved through the administration of regulatory T cells in addition to the bone marrow cells.

This therapeutic approach has now been implemented and investigated for the first time in a clinical trial under the leadership of Thomas Wekerle and Rainer Oberbauer (Division of Nephrology and Dialysis, Department of Medicine III, MedUni Vienna). The study, funded by the WWTF, was carried out in close interdisciplinary collaboration between several departments at MedUni Vienna (Clinical Trials Coordination Centre, Department of Transfusion Medicine and Cell Therapy, Institute of Clinical Biometrics, Department of Pediatrics and Adolescent Medicine, Department of Pathology) and the Leibniz Institute for Immunotherapy in Regensburg, as well as the University of Alberta in Canada.

Combined cell therapy in clinical kidney transplantation
In the pilot study, patients received both cell therapy with regulatory T cells and cell therapy with bone marrow cells from the kidney donor immediately after kidney transplantation. All patients developed what is known as chimerism, meaning that the donor’s leukocytes were detectable in the transplant recipients for a period of time. Compared to a control group that did not receive cell therapy, significantly better control of the immune response to the donor kidney and a positive change in the T-cell receptor repertoire were observed after twelve months. In several patients, immunosuppressive therapy could be reduced. “The results of the pilot study are promising for the application of this novel cell therapy and are intended to contribute to the ongoing improvement of outcomes following kidney transplantation,” said study leaders Rainer Oberbauer and Thomas Wekerle. The findings are to be further developed in future studies, bringing them closer to routine clinical use.

Publikation: Science Translational Medicine
Donor bone marrow together with recipient regulatory T cells induces chimerism without irradiation in kidney transplantation. 
Thomas Wekerle, Moritz Muckenhuber, Andreas Heinzel, Anna Marianne Weijler, Ana F. David, Verena Kainz, Karin Hu, Jasmin Mucha, Konstantinos Mengrelis, Roman Reindl-Schwaighofer, Georg A. Böhmig, Bruno Watschinger, Georg Györi, Thomas Soliman, Andreas Salat, Christoph Schwarz, Marlena Muhm, Georg Heinze, Michael Wolzt, Nina Worel, Michaela Fortschegger, Thomas Lion, Heinz Regele, Gabriela Berlakovich, Philip F. Halloran, Matthias Edinger, Rainer Oberbauer.
Sci. Transl. Med. 2026, DOI: 10.1126/scitranslmed.aee6850
https://www.science.org/doi/10.1126/scitranslmed.aee6850