Monitoring patients after islet transplant failure
Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss
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 |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT02000687 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals with a history of at least one islet transplant who have experienced complete graft loss.
Not a fit: Patients who have undergone any solid organ transplant or are unable to provide informed consent may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Miami, Florida
- Diabetes Research Institute — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Rodolfo Alejandro, MD — University of Miami
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.