Islet Transplant Alone in OMENtum

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

April 30, 2016

Primary Completion Date

December 31, 2023

Study Completion Date

December 31, 2024

Conditions
Islets of Langerhans TransplantationDiabetes Mellitus, Type 1
Interventions
BIOLOGICAL

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

Trial Locations (1)

20132

IRCCS San Raffaele Scientific Institute, Milan

All Listed Sponsors
lead

Lorenzo Piemonti

OTHER