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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
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
Primary Outcome Measures
NameTimeMethod
concentration of autoreactive t-cellsMeasured weekly in first 8 weeks, then every other week for weeks 8-12
Secondary Outcome Measures
NameTimeMethod
Concentration of TNF, TNF-receptors, other cytokines, and c-peptide levelsWeekly 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

Diabetes Research Center at Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States

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