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This experimental combination therapy, often referred to as the TILT (Tregs + IL-2 for Type 1 Diabetes) protocol, consists of autologous polyclonal regulatory T cells (PolyTregs) and low-dose interleukin-2 (IL-2). Developed by Jeffrey Bluestone and colleagues at the University of California, San Francisco (UCSF), the therapy is designed to treat recent-onset type 1 diabetes mellitus by restoring immune tolerance. The PolyTregs are ex vivo-expanded CD4+CD127lo/-CD25+ cells derived from the patient's own blood. These cells are intended to suppress the autoimmune destruction of pancreatic beta cells. Low-dose IL-2 (aldesleukin) is administered as an adjuvant to enhance the survival, stability, and expansion of the infused PolyTregs as well as endogenous Treg populations. A Phase 1 dose-escalation study demonstrated that the combination was safe and successfully increased Treg frequencies, although it did not show a significant preservation of C-peptide levels in the small cohort studied.
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