Therapy: Ex vivo expanded human autologous CD4+CD127lo/-CD25+ Polyclonal Regulatory T Cells and Proleukin

Study Name: A Phase I Trial of CD4+CD127lo/-CD25+ Polyclonal Treg Adoptive Immunotherapy with Interleukin-2 for the Treatment of Type 1 Diabetes

Study Sponsors: Jeffrey A. Bluestone, PhD

Principal Investigator: Stephen E. Gitelman, MD

Who can sign up for this study? Volunteers must be 18-45 years old and diagnosed with type 1 diabetes for at least 100 days but no more than two years.

In addition, volunteers cannot have any of the following conditions:

  • No cancer
  • No pregnancy or breastfeeding

What is this study about? The UCSF Type 1 Diabetes Research Program is conducting a study to assess the safety of Tregs + IL-2 and survival of Tregs in recently diagnosed T1DM individuals. This study will contribute to research testing if Tregs can stop the destruction of the insulin making cells in people diagnosed with type 1 diabetes.

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, and provide blood and urine for tests. Volunteers who qualify and are enrolled will receive a single infusion of ex vivo selected and expanded autologous polyclonal Tregs plus two 5-day courses of Interleukin-2 (IL-2). You cannot choose which group you will be in. All volunteers will be monitored for 3 years to assess their overall health and to perform laboratory testing to determine the effects of the treatment. 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 approximately three years.

Reimbursement: You will not be charged for any of the study treatments and may be eligible for reimbursement for your time and effort.

For more information please contact: [email protected] or call 844-T1D-UCSF (844-814-8273).