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Transplantation Immunology

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Clinical tolerance trial (WWTF)

Principal Investigator: Thomas Wekerle

Institution: Medical University of Vienna

Project title: Combination cell therapy for immunomodulation in kidney transplantation


Rainer Oberbauer (Medical University of Vienna) (Co-Principal Investigator)

Matthias Edinger (University Hospital Regensburg) (Co-Principal Investigator)

Status: Ongoing (15.03.2019 – 14.03.2024) 60 months

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Outcome after kidney transplantation is unsatisfactory since mandatory immunosuppressive drug therapy is associated with high morbidity and cannot prevent late graft loss. The induction of donor-specific immunological tolerance would be a solution to this clinical problem. However, no tolerance protocol is available for routine clinical use, mainly due to unresolved safety issues. In extensive pre-clinical research, we developed a novel tolerance protocol that combines two types of cell therapy. Treatment with polyclonal recipient T regulatory cells (Tregs) together with the transplantation of donor bone marrow (BM) established tolerance without the need for myelosuppression by irradiation or cytotoxic drugs, thereby substantially improving safety. We therefore propose to perform an academic phase I/IIa, feasibility, safety and efficacy clinical trial in which HLA-mismatched living-donor kidney transplant recipients will be treated with recipient Tregs and donor BM cells without myelosuppressive recipient conditioning. The aim is to demonstrate for the first time that this combination cell therapy is feasible, safe and efficacious and allows the step-wise reduction of immunosuppression so that patients can be maintained on drug monotherapy and might ultimately be completely taken off immunosuppression. The results of this trial are expected to provide proof-of-concept that combination cell therapy is a novel treatment option for immunomodulation in organ transplantation.

Further information:


Milestone 1: Regulatory approval (IRB and AGES)
Milestone 2: Enrolment of first patient
Milestone 3: Treatment of first patient with Tregs and BM (study group)
Milestone 4: Interim analysis of immune monitoring data
Milestone 5: Enrolment of last patient
Milestone 6: Analysis of co-primary endpoint 2 (efficacy) of all patients


Oberbauer, R., Edinger, M., Berlakovich, G., Kalhs, P., Worel, N., Heinze, G., Wolzt, M., Lion, T. and Wekerle, T. 2020. A Prospective Controlled Trial to Evaluate Safety and Efficacy of in vitro Expanded Recipient Regulatory T Cell Therapy and Tocilizumab Together With Donor Bone Marrow Infusion in HLA-Mismatched Living Donor Kidney Transplant Recipients (Trex001). Front Med (Lausanne);7:634260; 10.3389/fmed.2020.634260

Muckenhuber, M., Mucha, J., Mengrelis, K., How, C., Reindl-Schwaighofer, R., Heinzel, A., Kainz, V., Worel, N., Berlakovich, G., Edinger, M., Oberbauer, R., Wekerle, T. 2023. Optimum timing of antithymocyte globulin in relation to adoptive regulatory T cell therapy. Am J Transplant;23(1):84-92.


Thomas Wekerle | © MedUni Wien/feelimage


Professor of Transplantation Immunology

Tel.: +43 (0)1 40400-39380

Kerstin Pöschl | © MedUni Wien/feelimage

Kerstin Pöschl, MSc

Office 9F
Tel.: +43 (0)1 40400-39381
Fax: +43 (0)1 40400-39382
Room 09.F9.13