Clinical phase 1 study in living kidney transplantation (TOL1 study)
The results of the Phase I study (TOL-1) in the transplantation of living donor kidneys showed excellent safety and tolerability and impressively demonstrated the efficacy of the TolerogenixX procedure.
No therapy-related side effects occurred in the patients. All patients showed above-average graft function. There were no organ rejection episodes. Long-term data of >60 months are available for all patients, showing stable graft function.
Through MIC therapy, the immune system of the donor organ recipient learns to tolerate the donor characteristics as its own characteristics. This has been clearly demonstrated in immunological tests. Nevertheless, the immune system shows its full strength of reaction to foreign characteristics. This shows that the immune system has retained its ability to defend itself against viruses, bacteria and tumor cells. This customized influence on the immune system is one of the clear advantages of MIC therapy over the conventional broad and non-specific weakening of the immune system by chemical substances.
Details of the TOL-1 study can be found in the following publications:
1-year follow-up: Morath et al, JCI, 2020: ttps://doi.org/10.1172/JCI133595.
3-year follow-up: Morath et al, JASN, 2023: 10.1681/ASN.2022020210
5-year follow-up: Schaier et al, Front Immunol, 2023: 10.3389/fimmu.2023.1089664