Clinical trial Recruiting at 1 site Observational Ages 18 to 75

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 typeObservational
Ages18 Years to 75 Years
SexAll
Enrollment60 (estimated)
SponsorUniversity of Miami
Academic / other
Locations1 site (Miami, Florida)
StatusRecruiting
StartedDecember 2008
Main results expectedDecember 2027
Study endsJuly 2028
Registry record updatedMarch 23, 2026
Trial IDNCT02000687 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.