Determination of Dosing and Frequency of BCG Administration to Alter T-Lymphocyte Profiles in Type I Diabetics
Phase 1
Completed
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Biological: BCGBiological: Saline
- Registration Number
- NCT00607230
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
Type 1 diabetes is caused by an autoimmune destruction of the insulin producing cells of the pancreas. The investigators have discovered the specific autoimmune cells responsible for destroying the insulin-producing cells in an animal model of type 1 diabetes, and the means of destroying those cells.
- Detailed Description
The investigators are now aiming to use a similar strategy (vaccination with BCG, the vaccine used world-wide to protect against tuberculosis) in human type 1 diabetes to see if the abnormal immune cells can be depleted. This is the first step in trying to cure established type 1 diabetes.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description E BCG BCG vaccination P Saline Saline vaccination
- Primary Outcome Measures
Name Time Method concentration of autoreactive t-cells Measured weekly in first 8 weeks, then every other week for weeks 8-12
- Secondary Outcome Measures
Name Time Method Concentration of TNF, TNF-receptors, other cytokines, and c-peptide levels Weekly for first 8 weeks, then every other week for weeks 8-12
Trial Locations
- Locations (1)
Diabetes Research Center at Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States