Islet Transplantation for Type 1 Diabetes
Diabetes Mellitus, Insulin-Dependent
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Insulin-Dependent
Eligibility Criteria
Inclusion Criteria Patients may be eligible for this study if they: Have had Type 1 diabetes mellitus for more than 5 years, and are exhibiting 1 of the following, despite intensive insulin management efforts: a) hypoglycemic unawareness, as defined by inability to sense hypoglycemia until the blood glucose falls to less than 54 mg/dL; b) metabolic instability, with 2 or more episodes of severe hypoglycemia (defined as an event with symptoms consistent with hypoglycemia in which the patient requires the assistance of another person and which is associated with a blood glucose below 54 mg/dL) or 2 or more hospital visits for diabetic ketoacidosis over the last year; or c) despite efforts at optimal glucose control, progressive secondary complications of diabetes as defined by retinopathy, nephropathy, or neuropathy. Are 18 to 65 years of age. Exclusion Criteria Patients will not be eligible for this study if they: Have had severe cardiac disease as defined by: a) recent myocardial infarction within the past 6 months; b) angiographic evidence of non-correctable coronary artery disease; or c) evidence of ischemia on a functional cardiac exam. Actively abuse alcohol or substances, including cigarette smoking (must not have smoked within the last 6 months). Have psychiatric problems that prevent them from being a suitable candidate for transplantation (such as schizophrenia, bipolar disorder, or major depression that is not controlled or stable on current medication). Have a history of not following prescribed regimens. Have active infection including hepatitis C virus, hepatitis B virus, human immunodeficiency virus (HIV), or Tuberculosis (TB) (or under treatment for suspected TB). Have a history of malignancy, except squamous or basal skin cancer. Weigh more than 70 kilograms or have a Body Mass Index (BMI) greater than 26 kg/m^2 at time of screening. Have a C-peptide value of 0.3 ng/ml or more following a 5.0 gram intravenous arginine infusion challenge. Are unable to provide informed consent. Have gallstones or hemangioma in liver. Have untreated proliferative retinopathy. Are breast-feeding or pregnant, or intend to try and become pregnant (females) or to father a child (males), or fail to follow birth control methods. Have had a previous transplant, or evidence of anti-human leukocyte antigen (HLA) antibody. Have an insulin requirement of more that 0.7 International Units (IU)/kilograms/day. Have a blood glycosylated hemoglobin (HbA1c) higher than 12 percent. Are unable to reach the hospital for transplantation within 2 hours of notification. Have untreated or treated hyperlipidemia. Have a medical condition requiring chronic use of steroids. Use coumadin or other anticoagulants (aspirin is allowed). Have Addison's disease. Have a negative screen for Epstein-Barr virus (EBV).
Sites / Locations
- University of Miami
- Massachusetts General Hospital
- University of Minnesota
- Washington University
- Benaroya Research Institute at Virginia Mason Research Center
- University of Alberta
- Justus-Leibig University
- University of Milan
- University of Geneva
Arms of the Study
Arm 1
Experimental
Islet Transplantation
All study participants