An observational study in Type 1 Diabetes Mellitus, sponsored by Rodolfo Alejandro. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-23.
Sponsored by Rodolfo Alejandro · Observational
This is a single-center, prospective, open label study in islet transplant recipients following islet graft loss.
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. Primary objective is to determine the rate of allosensitization in patients 3 years after failed islet transplantation (i.e. stimulated c-peptide \<0.3mg/mL) and monitor the persistence of elevated PRA levels (≥ 20%) at year 3, 6, and 9. Timing, frequency and level of change in PRA will be monitored after all immunosuppression is discontinued.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's planned enrollment of 60 is below the median of 120 across 748 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Rodolfo Alejandro is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Ages 18-75 years old that received at least one IT. Participants will be obtained from the pool of islet transplant recipients transplanted at the Diabetes Research Institute at the University of Miami, Miller School of Medicine.
1. History of at least one islet alone transplant (ie islet transplant in the absence of any other organ transplant).
Exclusion Criteria:
determine the rate of allosensitization in patients after failed islet transplantation
Time frame: 10 years
Plan to share: Undecided
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Rodolfo Alejandro