Islet Transplantation for Type 1 Diabetes

Completed · Phase 2

Conditions studied: Diabetes Mellitus, Insulin-Dependent

In brief

The purpose of this study is to test whether the islet cell transplantation procedures and results from a previous study in Edmonton, Canada, can be repeated. The study also is designed to learn more about diabetes control using islet cell transplantation. This is a Phase I/II study (a study that examines effectiveness and looks for side effects). The transplanting of islet cells has been studied in Type 1 diabetic patients whose blood sugar levels will not stay normal, despite intensive insulin therapy. A recent study conducted in Edmonton, Canada, was able to demonstrate that islet transplantation led to insulin independence in a majority of the patients treated. This study extends the results obtained from the Edmonton study, which used islet transplantation in Type 1 diabetic patients with steroid-free immunosuppression.

Key facts

Study ID

NCT00014911

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

36

Starts

2001-04-01

Expected to finish

2010-08-01

Last updated by the study team

2017-03-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• University of Miami — Miami, Florida, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Benaroya Research Institute at Virginia Mason Research Center — Seattle, Washington, United States
• University of Alberta — Edmonton, Alberta, Canada
• Justus-Leibig University — Giessen, Germany
• University of Milan — Milan, Italy
• University of Geneva — Geneva, Switzerland

Full record on ClinicalTrials.gov

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