T regulatory cells (Tregs) are subsets of T lymphocytes specialized in modulating antigen-specific immune responses in vivo. Hence, Tregs represent an ideal therapeutic tool to control detrimental immune reactions. Based on solid pre-clinical results, investigators started testing the safety and efficacy of Treg-based therapies in humans. Despite promising results, a number of issues remain to be solved. We will discuss the results obtained from clinical trials and the challenges and risks we are facing in the further development of Treg-based therapies.
Keywords: FOXP3; IL-10; T regulatory cells; T regulatory type 1 cells; Treg-based therapy; gene transfer; tolerance.