Islet Transplantation for Patients With Type 1 Diabetes and Stable Renal Allografts Using Steroid Sparing Immunosuppression

Islet Transplantation for Patients With Type 1 Diabetes

Sponsors

Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Source National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Brief Summary

This protocol will test whether Type 1 diabetes (T1DM) can be reversed in patients with stable renal allografts by islet transplantation.

Detailed Description

We will test whether pancreatic islets isolated from cadaveric human donor pancreata can be transplanted into the portal vein of patients with T1DM who have stable renal allografts to achieve insulin independence for the recipient. The protocol will employ a defined islet isolation procedure, percutaneous islet infusion into the recipient's portal vein via an intra-portal catheter, tight glycemic control during the peri-transplant period, and an immunosuppressive protocol that avoids glucocorticoids.

Overall Status Completed
Start Date August 2003
Completion Date December 2004
Phase Phase 1
Study Type Interventional
Enrollment 10
Condition
Intervention

Intervention type: Procedure

Intervention name: Islet transplantation

Eligibility

Criteria:

- Patients with type 1 diabetes with stable renal allografts

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Mark Hardy, MD Principal Investigator Columbia Presbyterian Hospital
Location
facility Columbia Presbyterian Medical Center
Location Countries

United States

Verification Date

January 2010

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov