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

Other illness

• Known history of untreated severe hyperlipidemia, obesity, or refractory hypertension
• History of active infection including hepatitis B, hepatitis C, HIV, or TB.
• Any history of malignancy except for completely resected squamous or basal skin cell carcinoma.
• Evidence of inter-current infection.
• Active peptic ulcer disease

Lab values

• 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%.
• 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.

Other

• For female participants: Positive pregnancy test or presently breast-feeding.
• Known active alcohol or substance abuse.
• History on non-adherence to prescribed regimens including immunosuppression.
• PRA ≥ 50% or evidence of significant sensitization to be determined at discretion of the investigator.

• Male and female patients age 18-70 years of age.
• Ability to provide written informed consent.
• Mentally stable and able to comply with the procedures of the study protocol.
• Any subject currently prescribed immunosuppressive medications or discontinuation of immunosuppressive medications indicated as per current protocol of islet transplantation.
• History of at least one islet transplant.
• Stimulated C-peptide \<0.3 ng/ml.