Islet Transplantation for Patients With Type 1 Diabetes

National Institutes of Health (NIH)

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1

Treatments: Procedure: Islet transplantation

Study type: Interventional

Funder types: NIH

Identifiers

NCT00073281

9903 (completed)

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Patients with type 1 diabetes with stable renal allografts

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)