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Clinical Islet Transplantation Study (CIT)

          Exclusion Criteria (cont.)
    1. Presence or history of macroalbuminuria (>300mg/g creatinine).
    2. Presence or history of panel-reactive anti-HLA antibodies above background by flow cytometry
    3. For female subjects: 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. Oral contraceptives, Norplant®, Depo-Provera®, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable.
    4. Presence or history of active infection including hepatitis B, hepatitis C, HIV, or tuberculosis (TB). Subjects with laboratory evidence of active infection are excluded even in the absence of clinical evidence of active infection.
    5. Negative screen for Epstein-Barr Virus (EBV) by IgG determination.
    6. Invasive aspergillus, histoplasmosis, or coccidioidomycosis infection within one year prior to study enrollment.
    7. Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin.
    8. Known active alcohol or substance abuse.
    9. Baseline 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). Participants with lymphopenia are allowed if the investigator determines there is no additional risk and obtains clearance from a hematologist.
    10. Administration of live attenuated vaccine(s) within 2 months of enrollment.
    11. Any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial.
    12. Treatment with any immunosuppressive regimen at the time of enrollment.
    13. A previous islet transplant.
    14. A previous pancreas transplant, unless the graft failed within the first week due to thrombosis, followed by pancreatectomy and the transplant occurred more than 6 months prior to enrollment.

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