RecruitingPhase 2NCT01241864

Islet Transplantation in Type 1 Diabetic Kidney Allograft


Sponsor

University of Chicago

Enrollment

10 participants

Start Date

Dec 1, 2010

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to learn about the safety of islet transplantation when performed after kidney transplantation, 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: 68 Years

Plain Language Summary

Simplified for easier understanding

This study transplants insulin-producing islet cells (from a donor pancreas) into Type 1 diabetic patients who have already received a kidney transplant, with the goal of restoring the body's ability to produce insulin naturally. **You may be eligible if...** - You are between 18 and 68 years old with Type 1 diabetes diagnosed before age 40, and have been insulin-dependent for more than 5 years - Your body no longer produces any insulin (confirmed by a specific blood test) - You have received a kidney transplant at least 3 months ago and have stable kidney function - You are already taking immunosuppression medication to protect your kidney transplant **You may NOT be eligible if...** - You weigh more than 90 kg or have a BMI above 30 - You require very high or very low doses of insulin - You have received other organ transplants (besides kidney or a failed pancreas) - You have uncontrolled diabetic eye disease, high blood pressure, or poor kidney function - You are pregnant, breastfeeding, or plan to become pregnant - You have active hepatitis B, hepatitis C, HIV, or tuberculosis 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 varies but may include prograf, cellcept, sirolimus, prednisone. 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)

The University of Chicago

Chicago, Illinois, United States

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NCT01241864


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