People With Type 1 Diabetes: Age 18 and Older - Islet Cell Transplantation Using Belatacept

Study Name: Prevention of Autoimmune Destruction and Rejection of Human Pancreatic Islets Following Transplantation for Insulin Dependent Diabetes Mellitus

Study Sponsors:   Juvenile Diabetes Research Foundation

Principal Investigators:  Dr Peter Stock and Dr Andrew Posselt

Who can sign up for this study? Type 1 diabetics over 18 years of age, weighing less than 80kgs (175 lbs), with good kidney function and no previous transplant of any kind.  Other inclusion and exclusion criteria apply.

What is this study about?   Pancreatic islets are the part of the pancreas that produce insulin and help control the blood sugar.  This study aims to improve islet transplantation as a treatment for type 1 diabetes by using a new combination of immunosuppressive drugs that have been successful in treating other autoimmune diseases and in preventing kidney transplant rejection.

What will happen in this study?   Potential participants must complete an application process that includes submitting test results and other information from their regular doctors.  If all criteria are met, further evaluation will be done before the person is registered on a waiting list for transplant. Once a pancreas match is available, the person will be required to stay at the hospital for about 5 days to begin immunosuppression and receive the islet cells. During the first month after transplant, there are outpatient visits to UCSF every few days to monitor how well the islets are working.  Eventually, the visits are once a month.  The immunosuppressant drugs are started just before the transplant and may continue indefinitely.

How long will this study last?  The time from the start of the application process to the time of the transplant may be a few weeks to over a year.  It is possible the participant may receive up to two more islet transplants if the first one does not result in insulin independence.  The follow-up visits to UCSF will continue for 5 years after the last transplant. Some of the immunosuppressant drugs may be continued after the study is completed, especially if the islet transplant is at least partially working.

Reimbursement:  No payment to subjects.

For more information:  Please contact UCSF Islet Transplant Program at (415) 353-8893 or email islettransplant@ucsfmedctr.org