Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells

Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells is an investigational autologous cell therapy developed by the National Institute of Allergy and Infectious Diseases (NIAID) for the treatment of systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE). The therapy involves the isolation of a patient's own CD4+ CD25+ CD127lo regulatory T cells (Tregs), which are then expanded ex vivo to increase their numbers while maintaining high suppressive activity and stable Foxp3 expression, as evidenced by demethylation of the Treg-specific demethylated region (TSDR). The expanded cells are reinfused into the patient to restore immune tolerance and suppress the pathogenic autoimmune response characteristic of lupus. A Phase I dose-escalation trial, designated ALE08 (NCT02428309), was initiated to evaluate the safety and tolerability of this approach, although the study faced significant recruitment challenges and was ultimately terminated.

Other names

Autologous Polyclonal Regulatory T Cell TherapyAutologous Treg therapy