T1DM Immunotherapy Using CD4+CD127lo/-CD25+ Polyclonal Tregs
What is the purpose of this trial?
The investigational therapy under study in this trial, regulatory T cells (Tregs), offers the hope of stabilizing further destruction of insulin producing beta cells in type 1 diabetes. Tregs are a specialized subset of T cells that function to control the immune response. Pre-clinical studies in non-obese diabetic mice have demonstrated that adoptive transfer of Tregs can slow diabetes progression and, in some cases, reverse new onset diabetes. The primary purpose of this Phase 1 study is to assess the safety and feasibility of intravenous infusion of ex vivo selected and expanded autologous polyclonal Tregs in patients with type 1 diabetes (T1DM) to support dose selection for a future efficacy trial. The study also aims to assess the effect of Tregs on beta cell function as well as on other measures of diabetes severity and the autoimmune response underlying T1DM.
- 18 Years - 45 Years
- Juvenile Diabetes Research Foundation
National Institute of Allergy and Infectious Diseases (NIAID)
University of California, San Francisco
- November 2010
- Last Updated:
- November 16, 2012
- Study HIC#:
Clinicaltrials.gov ID: NCT01210664