Celular therapies based on thymus-derived regulatory T cells are found to be promising for suppressing undesired immune reactions in kidney transplantation. However, the exact effect and efficacy of regulatory T cells are not known. This study aims to evaluate whether the use of regulatory T cells (nTregs) can minimize immune suppression in kidney transplantation.
This monocenter, investigator-led, phase I/IIa, nTreg dose-escalation clinical trial included a total of 20 participants, 11 of which were recipients of a living donor kidney transplant, and 9 were in the reference group trial. All the participants were assigned to receive CD4+ CD25+ FoxP3+ nTreg products in three groups: 0.5, 1.0, or 2.5-3.0×10^6 cells/kg body weight. The primary outcome of the study was the incidence of biopsy-confirmed acute rejection.
The findings suggested that 40-50 mL of peripheral blood was sufficient for generating nTreg products with ample purity, yield, and functionality. None of the three-dose escalation groups were found to be having dose-limiting toxicity. The nTreg and reference groups had 100% 3-year allograft survival.
The research concluded that the use of autologous nTregs was found to be safe and feasible in patients who were immunosuppressed and had undergone a kidney transplant.