RecruitingNot ApplicableNCT01630850

Islet Transplantation in Patients With "Brittle" Type I Diabetes


Sponsor

University of Chicago

Enrollment

20 participants

Start Date

May 1, 2012

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to learn about the safety of islet transplantation for Type 1 diabetes mellitus, which may provide more normal control of blood sugar without the need for insulin shots. Islets are special clusters of cells within the pancreas that produce insulin. These cells will be obtained from cadaver (non-living) donors and given to subjects by vein.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether transplanting insulin-producing cells (called islets) from donor pancreases into people with extremely difficult-to-control Type 1 diabetes — known as 'brittle' diabetes — can stabilize blood sugar levels and reduce dangerous episodes of very low blood sugar. **You may be eligible if...** - You are between 18 and 70 years old - You have had Type 1 diabetes since before age 40 and have been insulin-dependent for at least 5 years - Your pancreas produces no measurable insulin on its own (confirmed by a specific test) - You have 'brittle' diabetes, meaning your blood sugar is very difficult to control despite best efforts - You are able to understand and follow the study procedures **You may NOT be eligible if...** - You are outside the age range of 18 to 70 - You still produce some of your own insulin - You have significant kidney disease, heart disease, or other conditions that make the procedure unsafe - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAllogenic islet cells (human, U. Chicago)

Human allogenic islet cells. Immunosuppression may include remicade, thymoglobulin,prograf, solu-medrol, and cellcept. Dosage will vary per patient based on weight. Patients will receive immunosuppression medications while islet cells are functioning.

PROCEDUREIntraportal infusion of islet cells

Intraportal infusion of islet cell through the portal vein in the liver.


Locations(1)

University of Chicago Medical Center

Chicago, Illinois, United States

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NCT01630850


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