CORDIS - EU research results
CORDIS

Advancing Innovative Stem Cell-based Therapy for Diabetes in Europe

Project description

Islets could change the medical landscape for diabetes patients

Diabetes is characterised by a high level of blood glucose that can lead to serious health problems. In both type 1 diabetes (T1D) and type 2 diabetes (T2D), this is related to levels of insulin, the hormone produced by the pancreas that enables blood sugar to enter cells and be used for energy. In T2D, insulin production is insufficient or the insulin produced does not work properly. By contrast, in T1D, the body attacks the cells in the pancreas, and they do not make any insulin. Currently, T1D is treated with lifelong insulin therapy via injections or an insulin pump. The EU-funded ISLET project's innovative programme is using stem-cell-based human pancreatic islet cells and developing the quality control assays that will lead to rapid commercialisation of a game-changing therapy for T1D.

Objective

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.

Call for proposal

H2020-SC1-BHC-2018-2020

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Sub call

H2020-SC1-2019-Single-Stage-RTD

Coordinator

HELMHOLTZ ZENTRUM MUENCHEN DEUTSCHES FORSCHUNGSZENTRUM FUER GESUNDHEIT UND UMWELT GMBH
Net EU contribution
€ 3 186 087,43
Address
INGOLSTADTER LANDSTRASSE 1
85764 Neuherberg
Germany

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Region
Bayern Oberbayern München, Landkreis
Activity type
Research Organisations
Links
Total cost
€ 3 186 087,43

Participants (7)