RecruitingNCT01999374

Long Term Follow up of Recipients of Functional Islet Allografts


Sponsor

Rodolfo Alejandro

Enrollment

30 participants

Start Date

Mar 1, 2013

Study Type

OBSERVATIONAL

Conditions

Summary

Since its inception, the Diabetes Research Institute (DRI) has made significant contributions to the field of diabetes, pioneering many of the techniques used in diabetes centers around the world. Through several clinical trials, DRI has demonstrated that diabetes can be successfully reversed as a result of islet cell transplant. Over the years the following protocols in islet cell transplantation have been initiated: 2000/0329; 2000/0196; 2004/0205; 2000/024; 2006/0200; 2006/0508; 2006/0210. All of the studies listed above will be source of study subjects for this study. Approximately 30 subjects are expected to be enrolled and followed in this trial. After islet-cell transplantation in the parent studies, each subject receives maintenance immunosuppressive medications. The purpose of this protocol is to collect additional follow-up for safety and efficacy from subjects with graft function after their completion in their parent study. It is expected that most subjects will retain measurable islet function and, in the islet-alone studies, continue to receive immunosuppressive medications at the time of completing their parent study.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is following people who received an islet cell transplant — a procedure where insulin-producing cells are transplanted into the body to help control blood sugar in type 1 diabetes — to track their long-term health outcomes and how well the transplant continues to work over many years. **You may be eligible if...** - You have type 1 diabetes and have previously received an islet cell transplant at a participating center - Your transplanted islet cells are still functioning (your body is producing some insulin from the donated cells) - You are willing to attend annual follow-up visits and provide blood and urine samples **You may NOT be eligible if...** - Your islet transplant has completely failed and no cells remain functional - You are unable to return for required annual check-ups - You received your transplant at a non-participating facility and your records cannot be transferred 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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Locations(1)

Diabetes Research Institute

Miami, Florida, United States

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NCT01999374


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