Long Term Surveillance of IsletTransplant Recipients Following Complete Graft Loss
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
Read our disclaimer for details.
This is a single-center, prospective, open label study in islettransplant recipients following islet graft loss.
Condition or disease
Type 1 Diabetes Mellitus
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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).
Inability to provide written informed consent.
Mentally unstable and/or unable to comply with the procedures of the study protocol.