NCT01123187

Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation

Phase 2 Study of Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation With Steroid Free Immunosuppression

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This single center phase 2 clinical trial, is designed for confirming the efficacy and safety of sequential islet allotransplantation with steroid free immunosuppression in patients with previous kidney transplantation.

Detailed description

The beneficial effects of glycemic control on both survival and function of transplanted kidneys in patients with type 1 diabetes mellitus have been recognized. The purpose of this study is to reverse hyperglycemia and insulin dependency, by islet cell transplantation, in patients with type 1 diabetes mellitus who have a stable kidney allograft. The study primary efficacy endpoint is graft survival defined as insulin independence and HbA1c \< 8% at 1 year post first transplant. Secondary outcomes are graft function and metabolic control The immunosuppression protocol for the kidney graft was converted to sirolimus+tacrolimus regimen 6 months before islet transplantation to exclude negative effects on kidney graft function.

Conditions

• Type 1 Diabetes
• Organ Transplantation
• Immunosuppression

Interventions

Type	Name	Description
PROCEDURE	islet transplantation	Islet transplantation consisted of up to three sequential fresh islet infusions within three months. Access to the portal vein was gained under general anesthesia by percutaneous catheterisation of a peripheral portal branch under ultrasound guidance or by surgical catheterisation of a small mesenteric vein.

Timeline

• Start date: 2003-03-01
• Primary completion: 2014-03-01
• Completion: 2016-04-01
• First posted: 2010-05-14
• Last updated: 2025-11-28

Locations

1 site across 1 country: France