Islet Transplantation in Type 1 Diabetic Kidney Allograft
University of Chicago
Summary
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.
Eligibility
- Age range
- 18–68 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male and female subjects age 18 to 68 years. * 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 disease onset \< 40 years of age and insulin-dependence for \> 5 years at the time of enrollment, and a sum of subject age and insulin dependent diabetes duration of \> 28. * Absent stimulated c-peptide (\< 0.3 ng/mL) in response to a MMTT \[Boost® 6 mL/kg body weight (BW) to a maximum of 360 mL; another product with equivalent caloric and nutrient content may be subst…
Interventions
- BiologicalAllogenic islet cells (human, U. Chicago)
Human allogenic islet cells. Immunosuppression varies but may include prograf, cellcept, sirolimus, prednisone. 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
- The University of ChicagoChicago, Illinois