NCT00073281

Islet Transplantation for Patients With Type 1 Diabetes

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (planned)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
PROCEDURE	Islet transplantation

Timeline

• Start date: 2003-08-01
• Completion: 2004-12-01
• First posted: 2003-11-20
• Last updated: 2010-01-15

Locations

1 site across 1 country: United States