Prevention of Autoimmune Destruction and Rejection of Human Pancreatic Islets Following Transplantation for Insulin Dependent Diabetes Mellitus

Exclusion Criteria

• •Patient weighs more than 80kg or body mass index BMI\>28
• •Patient's insulin requirement is \>55 Units/day.
• •Current use of immunosuppressive agents.
• •History of malignancy within 10 years (except for adequately treated basal or squamous cell CA of the skin).
• •Active peptic ulcer disease.
• •Severe unremitting diarrhea or other GI disorders potentially interfering with the ability to absorb oral medications.
• •Untreated proliferative retinopathy.
• •Pregnancy or breastfeeding.
• •Female subjects not post-menopausal or surgically sterile, or not using an acceptable method or contraception.
• •Active infections.
• •Major ongoing psychiatric illness.
• •Ongoing substance abuse, drug or alcohol; or recent history of noncompliance.
• •Portal hypertension or history of significant liver disease.
• •Lymphopenia (\<1000/ul) or leukopenia (\<3000 total leukocytes/ul) or an absolute CD4 count \<500/ul.
• •Presence or history of panel-reactive anti-HLA antibody \>20%.
• •Evidence of acute EBV infection (IgM\>IgG) OR no serologic evidence of previous exposure to EBV (IgG\>IgM).
• •Serologic evidence of infection with HIV or HbsAg or HCV Ab positive.
• •Creatinine clearance \<60ml/min/m2.
• •Positive lymphocytoxic cross-match using donor lymphocytes and serum