Summary
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.
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.
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| Web resources: | https://cordis.europa.eu/project/id/874839 |
| Start date: | 01-03-2020 |
| End date: | 28-02-2025 |
| Total budget - Public funding: | 7 999 998,00 Euro - 7 999 998,00 Euro |
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Original 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.
Status
SIGNEDCall topic
SC1-BHC-07-2019Update Date
26-10-2022
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