Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss

After complete islet graft loss is determined, patient's maintenance immunosuppression (i.e.
sirolimus and tacrolimus) will be discontinued and they will be placed on Myfortic®
monotherapy for 2 years thereafter. After completion of two years of Myfortic® maintenance
monotherapy, it will be weaned and subjects will be monitored over the subsequent twelve
months, for the appearance of sensitization using panel reactive antibody (PRA) levels.

Inclusion Criteria:

1. Male and female patients age 18-70 years of age.

2. Ability to provide written informed consent.

3. Mentally stable and able to comply with the procedures of the study protocol.

4. Any subject currently prescribed immunosuppressive medications or discontinuation of
immunosuppressive medications indicated as per current protocol of islet
transplantation.

5. History of at least one islet transplant.

6. Stimulated C-peptide <0.3 ng/ml.

Exclusion Criteria:

1. Known history of untreated severe hyperlipidemia, obesity, or refractory hypertension

2. For female participants: Positive pregnancy test or presently breast-feeding.

3. History of active infection including hepatitis B, hepatitis C, HIV, or TB.

4. Any history of malignancy except for completely resected squamous or basal skin cell
carcinoma.

5. Known active alcohol or substance abuse.

6. Severe co-existing history of cardiac disease, characterized by a history of any one
of these conditions: recent myocardial infarction (within past 6 months), evidence of
ischemia on functional cardiac exam within the last year, or left ventricular ejection
fraction <30%.

7. History of persistent elevation of liver function tests. SGOT (AST), SGPT (ALT),
alkaline phosphatase or total bilirubin, with values >1.5 times normal upper limits
will exclude a patient.

8. Evidence of inter-current infection.

9. Active peptic ulcer disease

10. History on non-adherence to prescribed regimens including immunosuppression.

11. PRA ≥ 50% or evidence of significant sensitization to be determined at discretion of
the investigator.