Phase 2 Product Candidate for Recent-Onset Type I Diabetes
Caladrius is developing a T-regulatory (Treg) cell-based therapy (CLBS03) for the treatment of type 1 diabetes mellitus (T1DM), using the patient’s own Tregs. At the time of T1DM diagnosis, it is thought that 20% to 30% of the patient’s insulin-producing beta cells remain viable and, if protected from immune destruction, can be salvaged, thus making it possible for the patient to regain glycemic control and to decrease long-term risks of related complications1. Restoration of beta cells' viability and function can also potentially improve the T1DM patient’s quality of life by decreasing the patient’s dependence on exogenous insulin injections and risk for major hypoglycemia and long term micro- and macrovascular complications.
The Sanford Project: T-Rex Study Phase 2 in adolescents with recent onset T1D
The Sanford Project: T-Rex Study Executive Steering Committee
University of California, San Francisco
Peter Gottlieb, MD
University of Colorado
Kurt Griffin, MD, PhD
Kevan Herold, MD
Yale Diabetes Center
Antoinette Moran, MD
University of Minnesota
- Lernmark Å. (2013) Depleting t cells in newly diagnosed autoimmune (type 1) diabetes—are we getting anywhere? Diabetes, 62:3669-3670.
- Bluestone, J., et al. (2015) Type 1 diabetes immunotherapy using polyclonal regulatory T cells. Science Translational Medicine, 7 (315).
- Marek-Trzonkowsa, N., et al. (2014) Therapy of type 1 diabetes with CD4(+)CD25(high)CD127-regulatory T cells prolongs survival of pancreatic islets - results of one year follow-up. Clin Immunol., 7 (315): 315ra189. http://www.ncbi.nlm.nih.gov/pubmed/24704576