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Islet Transplantation in Patients With "Brittle" Type I Diabetes
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.
Details
| Lead sponsor | University of Chicago |
|---|---|
| Phase | NA |
| Status | RECRUITING |
| Enrolment | 20 |
| Start date | 2012-05 |
| Completion | 2030-06 |
Conditions
- Diabetes Mellitus, Type 1
Interventions
- Allogenic islet cells (human, U. Chicago)
- Intraportal infusion of islet cells
Primary outcomes
- HbAlc <7.0% and an absence of severe hypoglycemic events — 1 year
The proportion of subjects with an HbAlc \<7.0% at Day 365 AND free of severe hypoglycemic events from Day 28 to Day 365 inclusive following the first islet transplant.
Countries
United States