Start date 2020-03-01
End date 2025-03-01
Sponsor European Commission
Institution University of Copenhagen

Associated cell lines

Project Description

Type 1 diabetes (T1D) is one of the main health challenges, with 6 million European citizens affected. Today, T1D accounts for a severe economic burden on healthcare and labour force. To bring advanced therapy in type T1D to patients, a scalable source of pancreatic islets for transplantation is needed. The objective of the ISLET project is to build and implement a new and innovative program for the production and marketing of human pluripotent stem cell (hPSC)-derived advanced therapy medicinal products (ATMPs) for treatment of EU citizens with T1D. To achieve this, ISLET gathers a constellation of experts to establish a transferable GMP-compliant manufacturing program based on improved and standardised protocols for generation and characterisation of future ATMPs. Furthermore, to make a product closer to the “golden standard” human pancreatic islet, ISLET will develop islet-like clusters composed of isolated hPSC-derived alpha and beta-like cells, and advance strategies for safe, up-scaled production and a quantitative go/ no-go assessment of therapeutic quality. Specifically, to overcome the lack of robust qualitative and quantitative assays to assess islet function, ISLET will introduce a novel quality control concept for predicting the therapeutic efficacy by quantitative proteomics and lipidomics as part of the ATMP development chain - a concept that will be widely applicable. A commercial route for exploitation of hESC-derived ATMPs for T1D treatment with EU will be developed. Finally, a professionally supported dual plan for public engagement in the fields of stem cell therapy and diabetes is rounding up the project.