12
Participants
Start Date
April 30, 2016
Primary Completion Date
December 31, 2023
Study Completion Date
December 31, 2024
Biological: Islet transplantation
This is a single procedure protocol. Only a single islet transplant will be performed in the patient. Islets can be isolated from more than one pancreas donor. The final islet product is a sterile suspension of ≥70% viable, ≥30% pure, allogeneic islets. A minimum of 5000 IEQ/KG will be transplanted. Although this study is a single dose protocol, islet transplant recipients with partial islet graft function will be considered for a second islet transplant (intra-hepatic administration) if they do not achieve primary efficacy endpoint criteria at 1 year
IRCCS San Raffaele Scientific Institute, Milan
Lorenzo Piemonti
OTHER