Pancreatic Islet Cell Transplantation

Inclusion Criteria

• Patient has been fully informed and has signed an Institutional Review Board (IRB) approved informed consent form and is willing and able to follow study procedures for the full 2 years
• Patient is expected to receive an islet cell transplant (up to 3 infusions) for type I diabetes mellitus
• Type I diabetes of more than 5 years duration
• Age between 18 and 65
• Unstable diabetes mellitus control, as defined by glucose measurements above 200 mg/dL and/or below 80 mg/dL despite adequate medical care
• Hypoglycemia unawareness, as defined by episodes of loss of cognitive function
• Incapacitating signs and symptoms, as defined by the referring physician
• Poor control of HbA1c > 8%
• Psychogenically able to comply, in the opinion of the investigator
• Female patients of childbearing potential must have a negative urine or serum pregnancy test upon hospitalization or within 7 days prior to enrollment and have agreed to utilize effective birth control throughout the study as well as for 6 weeks following study completion.

Exclusion Criteria

Patients meeting any of the following criteria will be excluded from study participation.

• Patient has previously received or is receiving an organ or bone marrow transplant
• Patient has a known hypersensitivity to Tacrolimus, sirolimus, daclizumab, or CellCept
• Patient is pregnant or lactating
• Patient has participated in a blinded trial or participated in a trial involving a non-marketed (investigational) drug within 3 months of enrollment
• Patient has participated in a trial involving a marketed drug or an infusion device within 30 days of the start of the trial
• Glomerular filtration rate (GLOFIL) 1.6 mg/dL consistently
• Body mass index > 30
• Autoimmune thyroiditis
• Malignancy other than basal cell carcinoma or squamous cell carcinoma
• Radiographic evidence of pulmonary infection
• Evidence of liver disease
• Portal hypertension
• Active infections
• Hypercoagulable states (history of recurrent venous thrombosis, defined thrombophilia)
• Bleeding / coagulation disorders
• Basal insulin C-Peptide > 0.3 ng/dL
• Insulin C-peptide > 0.3 ng/dL during stimulation test
• HbA1c > 12%
• Insulin requirement > 1 IU/kg/day
• Seropositivity for Human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), Human T-cell leukemia virus-1 (HTLV-1)
• Abnormal Pap smear in the last two months, active gynecological infection
• Positive exercise or chemical tolerance test
• Steroid dependence
• Substance/alcohol abuse
• Untreated proliferating diabetic retinopathy aa) Purified protein derivative (PPD) conversion or positive PPD without isonicotinic acid hydrazide (INH) bb) No Primary care physician or primary care physician less than 6 months cc) Smoking in the last 6 months dd) Abnormal Complete Blood Count (CBC) / Hemoglobin 300 mg/24 hours ff) History of thyroid disease other than autoimmune disease gg) Untreated hyperlipidemia - Total Cholesterol (TC) > 240 mg/dL, Triglycerides (TGC) > 200 mg/dL, Low Density Lipoprotein (LDL) > 140 mg/dL hh) Untreated hyponatremia, hypokalemia, hypercalcemia, hypocalcemia ii) Iodine contrast allergy jj) Prostate Specific Antigen (PSA) > 4 kk) Panel Reactive Antibody (PRA) > 20% ll) Active peptic ulcer disease/gallstones/hemangioma mm) Abnormal mammogram