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Clinical Islet Transplantation Study (CIT)

          Exclusion Criteria (cont.)
     
    1. Untreated proliferative diabetic retinopathy.
    2. Blood Pressure: SBP >160 mmHg or DBP >100 mmHg.
    3. Measured glomerular filtration rate (using iohexol) of <80 mL/min/1.73m2 (or for subjects with an iodine allergy, calculated using the subject?s measured serum creatinine and the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation153). Strict vegetarians (vegans) with a calculated GFR <70 mL/min/1.73m2 are excluded. The absolute (raw) GFR value will be used for subjects with body surface areas >1.73 m2.
    4. Presence or history of macroalbuminuria (>300mg/g creatinine).
    5. Presence or history of panel-reactive anti-HLA antibodies above background by flow cytometry.
    6. 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.
    7. 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.
    8. Negative screen for Epstein-Barr Virus (EBV) by IgG determination.
    9. Invasive aspergillus, histoplasmosis, or coccidioidomycosis infection within one year prior to study enrollment.
    10. Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin.
    11. Known active alcohol or substance abuse.
    12. 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.
    13. A history of Factor V deficiency.
    14. Any coagulopathy or medical condition requiring long-term anticoagulant therapy (e.g., warfarin) after transplantation (low-dose aspirin treatment is allowed) or patients with an international normalized ratio (INR) >1.5.
    15. Severe co-existing cardiac disease, characterized by any one of these conditions:
      1. recent myocardial infarction (within past 6 months).
      2. evidence of ischemia on functional cardiac exam within the last year.
      3. left ventricular ejection fraction <30%.

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