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Islet Transplantation in Type 1 Diabetic Kidney Allograft
The purpose of this study is to learn about the safety of islet transplantation when performed after kidney transplantation, 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 | Phase 2 |
| Status | RECRUITING |
| Enrolment | 10 |
| Start date | 2010-12 |
| Completion | 2026-12 |
Conditions
- Diabetes Mellitus, Type 1
Interventions
- Allogenic islet cells (human, U. Chicago)
- Intraportal infusion of islet cells
Primary outcomes
- HbAlc <6.5% and an absence of severe hypoglycemic events — 1 year after transplantation
The proportion of subjects with both an HbAlc \<6.5% and an absence of severe hypoglycemic events at 1 year after the first islet transplant or a reduction in HbAlc of at least 1 point and an absence of severe hypoglycemic events at 1 year after the first islet transplant.
Countries
United States