Monitoring patients after islet transplant failure
Official title: Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss
Run by University of Miami · NCT02000687 · Data updated 2026-11-12
This study looks at patients who have lost their islet transplant for Type 1 Diabetes to see how stopping their immune-suppressing medications affects their antibody levels over the next 10 years.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Status | Recruiting |
| Started | December 2008 |
| Main results expected | December 2027 |
| Study ends | July 2028 |
| Registry record updated | March 23, 2026 |
| Trial ID | NCT02000687 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals with a history of at least one islet transplant who have experienced complete graft loss.
✕Probably not a fit
Patients who have undergone any solid organ transplant or are unable to provide informed consent may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on patients who have experienced complete graft loss following islet transplantation for Type 1 Diabetes Mellitus. After confirming graft loss, the study will discontinue the patients' immunosuppressive medications and monitor them for 10 years. The primary goal is to assess the rate of allosensitization by measuring panel reactive antibody (PRA) levels at specified intervals. The study aims to understand the persistence of elevated PRA levels and the implications for future transplants.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the immune response of patients after islet transplant failure, potentially guiding future transplant strategies.
How similar studies have gone: While there may be limited studies specifically focused on long-term outcomes after islet graft loss, similar approaches in transplant immunology have shown promise in understanding allosensitization.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1\. History of at least one islet alone transplant (ie islet transplant in the absence of any other organ transplant). Exclusion Criteria: 1. Inability to provide written informed consent. 2. Mentally unstable and/or unable to comply with the procedures of the study protocol. 3. History of any solid organ transplant.
Where it's running
-
Diabetes Research Institute
Miami, Florida, United States Recruiting
Study contacts
- Principal investigator: Rodolfo Alejandro, MD — University of Miami
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.