Islet Allotransplantation With Steroid Free Immunosuppression

PHASE2CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

May 31, 2003

Primary Completion Date

October 31, 2007

Study Completion Date

February 28, 2009

Conditions
Type 1 DiabetesHypoglycemiaMetabolic Diseases
Interventions
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.

DRUG

daclizumab - sirolimus - tacrolimus

Immunosuppressive consisted of Tacrolimus, target through level at 3-6 ng/ml, Sirolimus, target through level at 12-15 ng/ml for three months and at 7-10 ng/ml thereafter. A five-dose induction course of Daclizumab 1mg/Kg was administered biweekly beginning one hour prior to the first infusion

Trial Locations (1)

59037

University Hospital of Lille, Lille

All Listed Sponsors
collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

lead

University Hospital, Lille

OTHER

NCT00446264 - Islet Allotransplantation With Steroid Free Immunosuppression | Biotech Hunter | Biotech Hunter