Pancreatic Islet Transplantation Into the Gastric Submucosa

Exclusion Criteria

• •6. Must be able to give written informed consent
• •1. Lymphopenia (\<1000/µL) or leukopenia ( \<3000 total leukocytes/µL)
• •2. Presence of panel-reactive anti-HLA antibody \>20%
• •3. Positive lymphocytotoxic cross-match using donor lymphocytes and serum
• •4. Evidence of acute EBV infection (IgM\>IgG) OR no serologic evidence of previous exposure to EBV (IgG\>IgM)
• •5. Calculated or measured GFR \< 50 ml/min/m2 in patients without a renal transplant.
• •6. Calculated or measured GFR \< 40 ml/min/m2 in patients with a renal transplant.
• •7. Portal hypertension or history of significant liver disease
• •8. History of malignancy within 10 years (except for treated basal or squamous cell CA of the skin)
• •9. Active peptic ulcer disease or other gastric mucosal abnormalities as identified on screening endoscopy
• •10. Severe unremitting diarrhea or other GI disorders potentially interfering with the ability to absorb oral medications
• •11. Untreated proliferative retinopathy
• •12. Pregnancy or breastfeeding
• •13. Female subjects not post-menopausal or surgically sterile who are sexually active but not using an acceptable method of contraception
• •14. Active infections
• •15. Serologic evidence of infection with HIV, or HbsAg or HCV Ab positive
• •16. Major ongoing psychiatric illness
• •17. Ongoing substance abuse, drug or alcohol; or recent history of noncompliance
• •18. Any condition that in the opinion of the Principal Investigator does not allow safe participation in the study
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