Overview

Islet Transplantation for Type 1 Diabetes

Status:
Completed
Trial end date:
2010-08-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:
Immune Tolerance Network (ITN)
Treatments:
Daclizumab
Ganciclovir
Ganciclovir triphosphate
Pentamidine
Sirolimus
Sulfamethoxazole
Tacrolimus
Trimethoprim
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).