Recent onset of type 1 diabetes: Age 18 to 45 years, within 2 YEARS of diagnosis –Regulatory T CellS (TREGS)
Study Name: Treatment of Type 1 Diabetes Mellitus with Polyclonal Tregs
Study Sponsors: Juvenile Diabetes Research Foundation, Immune Tolerance Network, BD Biosciences
Principal Investigator: Stephen E. Gitelman, M.D.
Who can sign up for this study? People recently diagnosed with type 1 diabetes. Volunteers must be 18 to 45 years old and have been diagnosed with type 1 diabetes within the past 2 years.
In addition, volunteers cannot have any of the following conditions:
- No active infection
- No history of cancer except skin cancer
- No pregnancy or breastfeeding
What is this study about? The UCSF Diabetes Center is conducting a study on an investigational (not approved by the FDA) product called Regulatory T Cells (Tregs) to see if it is safe for humans. This study will support a future study that will test if Tregs can stop the destruction of the insulin making cells in people diagnosed with type 1 diabetes within the last 2 years.
What will happen in this study? All volunteers will undergo a screening visit where they will be asked questions about their medical history, undergo a physical exam, a skin test for tuberculosis, and provide blood and urine for tests. Volunteers who qualify and are enrolled will donate a unit of blood, which will be used to multiply their own Tregs in the laboratory. Volunteers will receive one treatment of multiplied Tregs. All volunteers will be monitored for 5 years to assess their overall diabetes health and to perform laboratory testing to determine the effects of the treatment to their immune system and beta cells. This will require several visits to UCSF for laboratory testing during this period.
How long will this study last? Each volunteer will be followed for 5 years.
Reimbursement: You will not be charged for any of the study treatments and may be eligible for reimbursement for your time, effort and travel expenses.
For more information: Please contact Kathleen Fraser at 415-353-9084 or email kfraser@diabetes.ucsf.edu.