Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol

Prior treatment

• Previous transplant or PRA reactivity \>80%
• Treatment with antidiabetic medication other than insulin within 4 weeks of enrollment
• Use of any study medication within 4 weeks of enrollment
• Received live attenuated vaccine(s) within 2 months of enrollment

Other illness

• Co-existing cardiac disease: myocardial infarction within the past 6 months, angiographic evidence of non-correctable coronary artery disease, ischemia on functional cardiac exam, heart failure
• Psychiatric disorder: schizophrenia, bipolar disorder, or major depression that is unstable on medication
• History of non-adherence to prescribed regimens
• Active infection including hepatitis C, hepatitis B, HIV
• TB by history, current infection, or under treatment for suspected TB
• History of malignancies except squamous or basal skin cancer
• Family history of MEN2 or MCT
• Stroke within the past 6 months
• Medical condition requiring chronic use of steroids
• Addison's disease
• Allergy to radiographic contrast material
• Symptomatic peptic ulcer disease
• Severe unremitting diarrhea, vomiting, or other gastrointestinal disorders that could interfere with medication absorption
• Any medical condition that, in the opinion of the investigator, might interfere with safe participation

Lab values

• Creatinine clearance \<80 mL/min/1.73 m2 by 24-hour urine collection
• Serum creatinine consistently \>1.5 mg/dL
• HbA1c \>12%
• Hyperlipidemia (fasting cholesterol \>130 mg/dL or fasting triglycerides \>200 mg/dL
• Use of Coumadin or other antiplatelet or anticoagulant therapy, or PT-INR \>1.5

Age

• Age less than 18 or greater than 75 years

Other

• Active alcohol or substance abuse, including cigarette smoking (must be abstinent for six months)
• BMI \>27 kg/m2
• C-peptide response to glucagon stimulation, any C-peptide \>0.3 ng/mL
• Inability to provide informed consent
• Macroalbuminuria \>300 mg/24h
• Baseline Hb \<12 gm/dL in women, \<13 gm/dL in men
• Baseline liver function tests outside normal range
• Untreated proliferative retinopathy
• Positive pregnancy test, intent for pregnancy, male's intent to procreate, unwilling to use effective contraception, breast feeding
• Insulin requirement \>0.7 IU/kg/day
• Factor V deficiency
• Smoking tobacco
• Symptomatic cholecystolithiasis
• Acute or chronic pancreatitis

• Type 1 diabetes mellitus for more than 5 years complicated by the following situations that persist despite intensive insulin management efforts:
• At least one episode of severe hypoglycemia in the past 3 years defined as an event with symptoms compatible with hypoglycemia in which the subject required the assistance of another person, and which was associated with either a blood glucose level \<50 mg/dL (2.8 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration
• Reduced awareness of hypoglycemia, defined by the absence of adequate autonomic symptoms at capillary glucose levels of \<54 mg/dL (3 mmol/l) as reported by the subject