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Method for generating individualized immunosuppression in organ transplantation and autoimmune diseases
TolerogenixX - TOL-1 Study
The state of the art in transplantation is the burdensome quadruple immunosuppression, which leads to rejection in more than half of cases and is often associated with considerable side effects, especially infections, malignancies and cardiovascular complications.
Previous attempts at individualized immunosuppression or tolerance generation have either had many side effects, been time-consuming or ineffective.
The TolerogenixX procedure achieves a targeted individualized modification of the body's own immune system, making artificial drug suppression of the immune system no longer necessary in future.
The TolerogenixX procedure can be used as a protective vaccine and for the treatment of autoimmune diseases. The target group is patients with organ transplants and autoimmune diseases.
The innovative approach of the TolerogenixX procedure is the rapid and simple implementation of individualized immunosuppression in clinical routine while avoiding the side effects of general immunosuppression. The application of the principle of individualized immunosuppression is initially planned for rejection prophylaxis after kidney transplantation and later for the treatment of various autoimmune diseases (e.g. systemic lupus - SLE).
For transplantation, donor blood cells are treated with mitomycin C (MICs) and then administered to the recipient.
In autoimmune diseases, patient blood cells are treated with mitomycin C and a specific autoantigen and then returned to the patient.
In both cases, the unique selling point is the modification of immunocompetent cells away from an activating reaction of the antigen towards a suppressive effect.
A single-arm phase 1 study is currently underway to test the safety and feasibility of intravenous administration of mitomycin C-treated mononuclear cells from the donor's peripheral blood (MICs) to generate individualized immunosuppression in living kidney transplantation (TOL-1 Study).
Projekt-Leitung
Prof. Dr. med. C. Morath
christian_morath@med.uni-heidelberg.de
+49 6221 9112 0
Persons involved
Dr. med. Matthias Schaier
Prof. Dr. med. Martin Zeier
Prof. D. M. Schmitt, GMP Core Facility
PD Dr. A. Schmitt, GMP Core Facility
Dr. C. Kleist, Transplantation Immunology
Prof. Dr. P. Terness, Transplantation Immunology
Prof. Dr. G. Opelz, Transplantation Immunology