Islet Transplantation for Patients With Type 1 Diabetes

NCT ID: NCT00073281

Last Updated: 2010-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2004-12-31

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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Islet transplantation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with type 1 diabetes with stable renal allografts

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: lead

Principal Investigators

Mark Hardy, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia Presbyterian Hospital

Locations

Columbia Presbyterian Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

9903 (completed)

Identifier Type: -

Identifier Source: org_study_id