Five-year follow-up of a phase I trial of donor-derived modified immune cell infusion in kidney transplantation

Background The administration of modified immune cells (MIC) before kidney transplantation led to specific immunosuppression against the allogeneic donor and a significant increase in regulatory B lymphocytes. We wondered how this approach affected continued clinical course these patients. Methods Ten patients from phase I trial who had received MIC infusions prior were retrospectively compared 15 matched standard-risk recipients. Follow-up was until year five after surgery. Results 10 an excellent with stable graft function, no donor-specific human leukocyte antigen antibodies (DSA) or acute rejections, opportunistic infections. In comparison, control group receiving standard immunosuppressive therapy higher frequency DSA (log rank P = 0.046) more infections 0.033). Importantly, patients, particular four highest cell number 7 days surgery low during follow-up, show lack anti-donor T lymphocyte reactivity vitro high CD19 + CD24 hi CD38 transitional CD27 memory lymphocytes Conclusions together reduced conventional associated good function years de novo development future, might contribute protection while reducing side effects therapy. However, needs further validation direct comparison prospective controls. Trial registration https://clinicaltrials.gov/ , identifier NCT02560220 (for TOL-1 Study). EudraCT Number: 2014-002086-30.