NCT00579371

Cadaveric Islet Transplantation in Patients With Insulin-Dependent Diabetes Mellitus

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

We hypothesize that the following improvements to islet transplantation will increase the islet mass successfully isolated and allow for engraftment from a single pancreas. The improvements are: * Using Two-Layer method preservation to improve pancreas quality before islet isolation * Maintaining isolated islets in culture before transplantation * Using a steroid-free immunosuppression regimen * Transplanting the best combination of donor and recipient possible after human leukocyte antigens (HLA) screening and final crossmatching

Detailed description

We hypothesize that the following improvements to islet transplantation will increase the islet mass successfully isolated and allow for engraftment from a single pancreas: using Two-Layer method preservation to improve pancreas quality before islet isolation, maintaining isolated islets in culture before transplantation, using a steroid-free immunosuppression regimen, and transplanting the best combination of donor and recipient possible after HLA screening and final crossmatching.

Conditions

• Islets of Langerhans Transplantation
• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	Islets of Langerhans	Subjects will receive islets isolated from one donor pancreas per transplantation event. Subjects will receive a cumulative dose of 8,000IE/kg. Islets will be infused intraportally. If necessary, additional transplantation events will be performed.

Timeline

• Start date: 2004-03-17
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2007-12-24
• Last updated: 2023-12-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study