Islet Cell Transplantation Alone in Patients With Type 1 Diabetes Mellitus: Steroid-Free Immunosuppression

Exclusion Criteria

• •1. c-peptide \> 0.3ng/ml basal or stimulated;
• •2. untreated proliferative diabetic retinopathy;
• •3. HbA1C \>12%;
• •4. creatinine clearance \<60;
• •5. serum creatinine consistently \>1.6 mg/dl;
• •6. macroalbuminuria \>300mg albumin in 24 hours;
• •7. presence of panel reactive antibodies (PRA) \>20%;
• •8. previous/concurrent organ transplantation (except previous unsuccessful islet cell transplant;
• •9. malignancy or previous malignancy (except non-melanomatous skin cancer);
• •10. x-ray evidence of pulmonary infection;
• •11. active infections;
• •12. active peptic ulcer disease, gall stones, hemangioma, or portal hypertension
• •13. serological evidence of HIV, HbsAg or HCV; serological evidence of active EBV (IgM\>IgG) or EBV negative serology;
• •14. PPD conversion or positive PPD without historic completion of appropriate prophylactic treatment;
• •15. abnormal liver function test;
• •16. anemia (hemoglobin \<12.0);
• •17. hyperlipidemia (fasting serum triglycerides \>200mg/dl and/or fasting serum cholesterol \>240 mg/dl and/or fasting LDL cholesterol \>140 mg/dl);
• •18. BMI above 26;
• •19. unstable cardiovascular status; prostate specific antigen (PSA) \>4;
• •20. pregnancy or breastfeeding;
• •21. sexually-active females who are not: a) post-menopausal, b) surgically sterile, or c) not using an acceptable method of contraception (oral contraceptives, Norplant, Depo-Provera, and barrier devices are acceptable; condoms used alone are not acceptable);
• •22. alcohol abuse, substance abuse or smoking within the previous 6 months; insulin requirement \>1u/kg/day and any condition or any circumstance that makes it unsafe to undergo an islet cell transplant.