Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 75 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 10 years
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "After complete islet graft loss is determined, patient's maintenance immunosuppression (i.e. sirolimus, tacrolimus, MMF and/or Myfortic®) will be discontinued and they will be monitored for 10 years thereafter, for the appearance of allosensitization using panel reactive antibody (PRA) levels and monitor the persistence of elevated PRA levels."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study follows people whose islet transplant has completely stopped working. Islets are groups of cells that make insulin, which helps control blood sugar. The study is for people who had an islet transplant without any other organ transplant.
This is a single-center, prospective, open label study in islet transplant recipients following islet graft loss.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Had at least one islet transplant without another organ transplant.
Who can't join
- Cannot give written consent to take part in the study.
- Have an unstable mental health condition or cannot follow the study steps.
- Have ever had a solid organ transplant, such as a kidney or liver transplant.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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.
Study sites (1)
FL
- Diabetes Research Institute · Miami, FL 33136Rodolfo Alejandro, MD · Study contact · 305-243-5321 · islet@med.miami.eduAna M Alvarez, APRN · Study contact · 305 243-3389 · axa383@med.miami.eduRodolfo Alejandro, MD · Principal investigatorDavid A Baidal, MD · Sub-investigatorMore trials in Miami