Conditions: Diabetes Mellitus, Type I
Keywords: Type I diabetes Islet after Kidney Transplant Islet transplantation
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 7
Healthy volunteers: no

Brief summary:
The purpose of the study is to learn if islet transplantation is an effective treatment for Type 1 diabetes in people who have had a kidney transplant.

The primary objectives of the study are:

\- To set up islet transplantation in patients who have had a kidney transplant and who are using an immunosuppressive regimen that works

The Secondary objective of the study is:

* To find out if successful islet transplantation leads to improved metabolic control and reduced renal complication from diabetes

Detailed description:
Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence. For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft. Induction therapy for subsequent transplants will be 2doses of basiliximab.

All patients will receive Etanercept to promote engraftment.

Arms:
arm 1: Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.

For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.

Induction therapy for subsequent transplants will be 2 doses of basiliximab.

All patients will receive Etanercept to promote engraftment.

Interventions: intervention 1: Purified Pancreatic Islets intervention 2: Etanercept
Intervention descriptions: intervention 1: Islet after kidney transplant in patients with type I diabetes. intervention 2: Given as induction for islet cell transplant

Protocol document: