autologous CD4+CD25+FoxP3+ natural regulatory T cells

This is an autologous cell therapy consisting of natural regulatory T cells (nTregs) characterized by the CD4+CD25+FoxP3+ phenotype. Developed by Prof. Dr. Petra Reinke and colleagues at Charité - Universitätsmedizin Berlin as part of The ONE Study consortium, the therapy is intended to prevent kidney transplant rejection and enable the tapering of standard immunosuppressive regimens. The nTregs are isolated from the patient's peripheral blood, expanded ex vivo, and administered as a single intravenous infusion post-transplantation. The mechanism of action involves the restoration of immune homeostasis and the suppression of allo-reactive effector T cell responses, thereby promoting long-term graft tolerance. Results from the Phase I/IIa ONEnTreg13 trial (NCT02371434) indicated that the therapy is safe and can facilitate stable tacrolimus monotherapy in living-donor kidney transplant recipients.

Other names

nTregsautologous natural regulatory T cellsautologous CD4+CD25+FoxP3+ nTregs