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

Eligibility 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.
• 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.