Phase 2 Safety and Efficacy Study of CLBS03 Autologous T-Regulatory Cells in Adolescents with Recent Onset Type 1 Diabetes Mellitus
Children with type 1 diabetes (T1D) face lifelong struggles with controlling their blood sugar levels and, despite careful management, an increased risk of severe complications. Currently, there is no approved therapy that maintains or restores the insulin-producing pancreatic beta cells that are destroyed by this disease. Researchers at Caladrius Biosciences will take cells, called regulatory T cells (Tregs), from the patient’s own immune system, expand the number of those cells in the lab and return them to the patient to reduce the autoimmune attack on the insulin-producing cells in people with type 1 diabetes.
Prospective, randomized, double-blinded, placebo-controlled, proof-of-concept study.
Primary: Safety. Secondary: Efficacy.
Enrolling; Fast track and Orphan designations.