Islet Transplantation in Patients With "Brittle" Type I Diabetes
University of Chicago
Summary
The purpose of this study is to learn about the safety of islet transplantation for Type 1 diabetes mellitus, which may provide more normal control of blood sugar without the need for insulin shots. Islets are special clusters of cells within the pancreas that produce insulin. These cells will be obtained from cadaver (non-living) donors and given to subjects by vein.
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male and female patients 18 to 70 years of age. * Subjects who are able to provide written informed consent and to comply with the procedures of the study protocol. * Clinical history compatible with T1D with onset of disease at \< 40 years of age, insulin-dependence for ≥ 5 years at the time of enrollment, and a sum of patient age and insulin dependent diabetes duration of ≥ 28 and absent stimulated c-peptide (\<0.3ng/mL) in response to a mixed meal tolerance test (MMTT; Boost® 6 mL/kg body weight to a maximum of 360 mL; another product with equivalent caloric and nutri…
Interventions
- BiologicalAllogenic islet cells (human, U. Chicago)
Human allogenic islet cells. Immunosuppression may include remicade, thymoglobulin,prograf, solu-medrol, and cellcept. Dosage will vary per patient based on weight. Patients will receive immunosuppression medications while islet cells are functioning.
- ProcedureIntraportal infusion of islet cells
Intraportal infusion of islet cell through the portal vein in the liver.
Location
- University of Chicago Medical CenterChicago, Illinois