Who is sponsoring NCT00160732?

NCT00160732 is sponsored by University of Chicago.

What condition does NCT00160732 study?

NCT00160732 studies Diabetes Mellitus, Type 1.

What drugs are being tested in NCT00160732?

Interventions: Allogenic islet cells (human, U. Chicago), Intraportal infusion of islet cells.

What is the status of NCT00160732?

NCT00160732 is currently ACTIVE_NOT_RECRUITING.

Last reviewed 2025-12-02 · How we verify

Allogenic Islet Cells (Human, U. of Chicago) Administered Via Intraportal Infusion; and Immunosuppressive Therapy

NCT00160732 Phase 1/Phase 2 ACTIVE_NOT_RECRUITING

The purpose of this study is to determine the safety of transplanting human islet cells for controlling hyperglycemia in brittle and/or complex patients with type 1 diabetes. In addition, initial observations will be made with regards to the effectiveness of reversing hypoglycemia with this treatment. The "Edmonton Protocol" of using specific anti-rejection drugs without steroids is also being evaluated.

Details

Lead sponsor	University of Chicago
Phase	Phase 1/Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	50
Start date	2003-10
Completion	2030-10

Conditions

Diabetes Mellitus, Type 1

Interventions

Allogenic islet cells (human, U. Chicago)
Intraportal infusion of islet cells

Primary outcomes

decrease in insulin requirement - Subjects able to maintain fasting blood glucose concentrations below 126 mg/dL and 2-hour post prandial levels below 180 mg/dL will be considered to be insulin independent. — Monthly
decrease in incidence of hypoglycemic events — Monthly

Countries

United States