Minimal Islet Transplant at Diabetes Onset

PHASE2CompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

April 30, 2015

Primary Completion Date

May 31, 2018

Study Completion Date

December 31, 2023

Conditions
Diabetes Mellitus, Type 1
Interventions
BIOLOGICAL

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.

DRUG

ATG

ATG will be administered IV (central vein) at a total dose of 6 mg/kg up to day 6 post-transplant

DRUG

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

DRUG

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.

Trial Locations (1)

20132

IRCCS San Raffaele Scientific Institute, Milan

All Listed Sponsors
collaborator

Italian Diabetes Foundation

OTHER

lead

Ospedale San Raffaele

OTHER

NCT02505893 - Minimal Islet Transplant at Diabetes Onset | Biotech Hunter | Biotech Hunter