Long Term Surveillance of Islet Transplant Recipients Following Complete 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.

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.