drugset / Trial / NCT00579371

Cadaveric Islet Transplantation in Patients With Insulin-Dependent Diabetes Mellitus

NCT00579371

Phase 1/2 Terminated 30 enrolled University of Nebraska
NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2004-03-17
Primary completion
2011-03
Completion
2011-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Islets of Langerhans Cell therapy 8000 iu/kg Other