Long-Term Monitoring After Islet Transplant Failure for Type 1 Diabetes

This study looks at what happens after an islet transplant (a procedure to replace insulin-producing cells) for Type 1 Diabetes doesn't work. Specifically, it's observing how your body reacts when you stop taking medicines like sirolimus, tacrolimus, MMF, and Myfortic® that prevent your body from rejecting the transplant. The main goal is to see how often your body develops "allosensitization" (a reaction where your immune system becomes sensitive to foreign tissues) after your transplant has failed, and how long this sensitivity lasts. You can join if you are 18 to 75 years old, have Type 1 Diabetes, and have had at least one islet transplant without any other organ transplants. The study aims to understand the rate of allosensitization at 3 years after transplant failure and monitor it for 10 years.

Study design
This is an observational study, meaning researchers will watch what happens without giving new treatments. It plans to include 60 participants.
What's involved
After your islet transplant has failed, you will stop taking your immunosuppression medications and be monitored for 10 years. Your blood will be checked for allosensitization using panel reactive antibody (PRA) levels at 3, 6, and 9 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for 10 years after stopping immunosuppression.

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NCT02000687

Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss

Recruiting
Not specifiedAges 18–75Observational
Rodolfo Alejandro
~60 participants
Updated 2026-03-23 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
determine the rate of allosensitization in patients after failed islet transplantation
Measured over 10 years
Type 1 Diabetes Mellitus
1 sites across 1 states
Florida1
  • Rodolfo Alejandro, MD · PRINCIPAL_INVESTIGATOR · University of Miami

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  • determine the rate of allosensitization in patients after failed islet transplantation10 years