Islet After Kidney Transplantation (IAK) in Patients With Type 1 Diabetes

Exclusion Criteria

• •Poor renal allograft function (serum creatinine \> 1.6 mg/dl, creatinine clearance \< 60ml/min, albumin excretion \>300 mg/24hr)
• •History of acute rejection related to renal graft in last 12 months or "high risk" for acute rejection (more than one previous renal transplant, PRA \>25%, positive kidney crossmatch by B, T, flow cytometry)
• •Current immunosuppression therapy with corticosteroids \>5mg/day.
• •Significant liver disease (including elevation of liver enzymes \> twice the upper limit of normal for each of ALT and AST, bilirubin \> 2 mg/dl, albumin \< 3.5 g/dl, liver masses including portal vein thrombosis, evidence of portal hypertension, or significant, untreated gallbladder disease (i.e., gallstones).
• •Significant cardiovascular disease, including non-correctable coronary artery disease with ejection fraction \< 50% and/or recent myocardial infarction (within last 12 months); extensive peripheral vascular disease not correctable by surgery or untreated proliferative retinopathy.
• •Recent unresolved acute infection, or chronic infection, including tuberculosis, HIV, HBV, HCV, CMV or positive skin test for TB.
• •Any history of malignancy, except squamous or basal skin cancer or in situ cancer of the cervix.
• •Recent history of non-compliance, or inability to demonstrate capacity to comply with strict blood glycemic control and insulin pump therapy.
• •Psychiatric illness that is untreated, or likely to interfere significantly with transplantation despite treatment.
• •Presence of preformed antibodies on panel reactive antibody screening \> 25%.
• •Body mass index (BMI) greater than 30.
• •Age less than 18 years or greater than 65 years.
• •Presence of a chronic disease that must be chronically treated with one or more of the following medications: glucocorticoids, diazoxide, bumetanide, haloperidol, chlorpromazine, desipramine, doxepin, imipramine, levodopa, morphine, L-asparaginase, cyclophosphamide, isoniazid, heparin, nalidixic acid, or any other agents that may adversely influence glycemic control and which may confound the interpretation of Graft Success post-transplant.
• •Pregnant women, women intending future pregnancy, women of reproductive potential who are unable or unwilling to follow effective contraceptive measures for the duration of immunosuppressive therapy, and women presently breast feeding are ineligible due to the unknown effects of these drugs on the fetus and nursing infant.
• •Active alcohol or substance abuse, including cigarette smoking (must be abstinent for \> 3 months).
• •Hyperlipidemia (total cholesterol \> 260 mg/dl, LDL \> 130 mg/dl, and/or triglycerides \> 300 mg/dl) despite appropriate treatment.
• •Anemia (Hgb \< 12 g/dl) or other hematologic disorders that require medical attention.
• •Increased risk of bleeding (platelet count \< 80,000; INR \> 1.5), other chronic hemostasis disorders, or treatment with chronic anticoagulant therapy (i.e., heparin or warfarin).