Minimal Islet Transplant at Diabetes Onset

Summary

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).

Timeline

Start

2015-04

Primary completion

2018-05

Completion

2023-12

Publications

• Piemonti L, Bolla AM, Caretto A, Melzi R, Mercalli A, Sordi V, Monti P, Magistretti P, Lampasona V, Marzinotto I, Maffi P, Ramondetta M, Cagni N, Pedone E, Catarinella D, Cardillo M, Caldara R, Bosi E. Induction of immune education in type 1 diabetes through controlled allogeneic islet rejection at onset: a monocentric open-label pilot study. EClinicalMedicine. 2025 Dec 4;90:103685. doi: 10.1016/j.eclinm.2025.103685. eCollection 2025 Dec.

Drugs

Indications