Immunostem, the first experimental phase 1 and 2 clinical trial of cell and gene therapy

"Immunostem" is the first experimental phase 1 and 2 clinical study of cell and gene therapy to open at the Azienda Ospedale - University of Padua: it was officially presented this morning in the presence of the Azienda's general director, Paolo Fortuna, and the rector of the University of Padua, Daniela Mapelli.

The study stems from a collaboration between University of Padua (with Alessandra Biffi, Unipd professor and director of the UOC Pediatric Oncohematology) and University of Milan (with Paolo Fiorina, director of the UOC Endocrinology), who established an innovative SME - Altheia Science - which is a spin-off of both universities and sponsor of the clinical study already approved by AIFA. 

"Immunostem" is aimed at evaluating the safety and efficacy of an innovative gene therapy approach based on engineered autologous hematopoietic stem cells to express the PD-L1 molecule for the treatment of newly diagnosed type 1 diabetes, and aims to preserve insulin production. The study's principal investigator is Gian Paolo Fadini, director of the UOC Metabolic Diseases.

The trial involves the recruitment of 15 patients, with the Ospedale di Padova as the only clinical site.