14
Participants
Start Date
May 31, 2003
Primary Completion Date
October 31, 2007
Study Completion Date
February 28, 2009
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.
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
University Hospital of Lille, Lille
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
University Hospital, Lille
OTHER