6
Participants
Start Date
April 30, 2015
Primary Completion Date
May 31, 2018
Study Completion Date
December 31, 2023
Human pancreatic islet
One thousand and five hundred (1,500) equivalent islet for Kg of body weight, isolated from a single brain-dead donor, will be infused into the patient's liver.
ATG
ATG will be administered IV (central vein) at a total dose of 6 mg/kg up to day 6 post-transplant
Pegylated G-CSF
Pegylated G-CSF (6 mg/dose) will be administered SC every 2 weeks for 6 doses (12 weeks) beginning after the last ATG infusion
Rapamycin
Rapamycin will be administered orally at a starting dose of 0.2 mg/kg once a day, then targeted to blood trough level of 8-10 ng/mL and suspended one month after transplant.
IRCCS San Raffaele Scientific Institute, Milan
Italian Diabetes Foundation
OTHER
Ospedale San Raffaele
OTHER