NCT00888628

Study of Islet Transplantation in Type 1 Diabetic Kidney Transplant Recipients

Islet Transplantation in Type 1 Diabetic Kidney Allograft Recipients

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type I

Interventions

Type	Name	Description
BIOLOGICAL	Purified Pancreatic Islets	Islet after kidney transplant in patients with type I diabetes.
DRUG	Etanercept	Given as induction for islet cell transplant

Timeline

• Start date: 2009-05-01
• Primary completion: 2014-08-01
• Completion: 2016-08-01
• First posted: 2009-04-27
• Last updated: 2017-11-29
• Results posted: 2017-01-27

Locations

1 site across 1 country: United States