This is a prospective phase 2, single-arm, mono-center pilot study. It has been designed to
investigate whether giving the combination therapy consisting of minimal islet
transplantation (1500 EIQ/Kg body weight), Thymoglobulin® (ATG), Rapamune® (rapamycin) and
Neulasta® (pegfilgastrim) to patients with Type 1 Diabetes (T1D) at onset is safe and
secondarily, if it will preserve insulin production. It will involve 6 patients with
new-onset T1D. Each patient will be involved in the study for a screening period and a
post-islet transplantation study period of 52±2 weeks, to include 1 treatment cycles of 12
weeks, assessment during treatment and 5 follow-up visits scheduled at weeks 2±1 (14 days),
4±1 (month 1), 12±2 (month 3), 26±2 (month 6) and 52±2 (month 12).
Phase:
Phase 2
Details
Lead Sponsor:
Ospedale San Raffaele
Collaborators:
Fondazione Italiana Diabete Onlus Italian Diabetes Foundation