It has been demonstrated that severe burn per se may contribute to activation and proliferation of regulatory T cells (Treg). This characteristic phenomenon might allow Treg to function for a prolonged period of time to regulate immune response, and to induce suppression of T lymphocyte immune function. Different degrees of elevated levels of cytokines produced by Treg and activation markers on Treg surface could also be involved in the development of sepsis and fatal outcome in patients with severe burn. Thus, the regulation of Treg as a cellular therapeutic strategy might be important to the Th1/Th2 cytokine balance in burn patients complicated with sepsis.