Allogeneic Islet Cells Transplanted Onto the Omentum

Exclusion Criteria

• •1. Body Mass Index (BMI) \>30 kg/m2 or patient weight ≤50 kg.
• •2. Insulin requirement of \>1.0 IU/kg/day or \<15 U/day.
• •3. HbA1c \>10%.
• •4. Untreated proliferative diabetic retinopathy.
• •5. Blood Pressure: SBP \>160 mmHg or DBP \>100 mmHg.
• •6. Glomerular filtration rate \<80 mL/min/1.73 m2 (calculated).
• •7. Presence or history of macroalbuminuria (\>300mg/g creatinine).
• •8. Presence or history of panel-reactive anti-HLA antibodies.
• •9. For female subjects: Serum or urine Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 4 months after discontinuation. For male subjects: intent to procreate during the duration of the study or within 4 months after discontinuation or unwillingness to use effective measures of contraception. If sexually active, subject must use at least two medically accepted methods of birth control.
• •10. Presence or history of active infection including hepatitis B, hepatitis C, HIV, or tuberculosis (TB).
• •11. Negative screen for Epstein-Barr Virus (EBV) by IgG determination.
• •12. Invasive aspergillus, histoplasmosis, and coccidioidomycosis infection within one year prior to study enrollment.
• •13. Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin.
• •14. Active alcohol or substance abuse.
• •15. Hb below the lower limits of normal at the local laboratory; lymphopenia (\<1,000/µL), neutropenia (\<1,500/µL), or thrombocytopenia (platelets \<100,000/µL).
• •16. A history of Factor V deficiency.
• •17. Any coagulopathy or medical condition requiring long-term anticoagulant therapy.
• •18. Severe co-existing cardiac disease,
• •1. recent myocardial infarction (within past 6 months)
• •2. evidence of ischemia on functional cardiac exam within the last year) left ventricular ejection fraction \<30%.
• •19. Persistent elevation of liver function tests at the time of study entry.
• •20. Symptomatic cholecystolithiasis.
• •21. Acute or chronic pancreatitis.
• •22. Symptomatic peptic ulcer disease.
• •23. Gastrointestinal disorders potentially interfering with the ability to absorb oral medications.
• •24. Hyperlipidemia despite medical therapy (fasting LDL cholesterol \> 130 mg/dL, fasting triglycerides \> 200 mg/dl).
• •25. Chronic use of systemic steroids, except for the use of ≤5 mg prednisone daily, or an equivalent dose of hydrocortisone, for physiological replacement only.
• •26. Treatment with any anti-diabetic medications other than insulin within 4 weeks of enrollment.
• •23\. Use of any investigational agents within 4 weeks of enrollment. 24. Administration of live attenuated vaccine(s) within 2 months of enrollment. 25. Any medical condition that, in the opinion of the investigator, will interfere with the safe participation in the trial.
• •26\. Treatment with any immunosuppressive regimen at the time of enrollment. 27. A previous islet transplant. 28. A previous pancreas transplant 29. Inflammatory bowel disease. 30. History of intestinal obstructions. 31. Previous major abdominal surgery. 32. History of peritonitis.