Biomaterials for the treatment of diabetes mellitus

Specific challenge: Diabetes mellitus and its associated pathologies have become a major public health problem. They cause significant physical and psychological morbidity, disability and premature mortality among those affected and imposes a heavy financial burden on health services.[1]  The ultimate goal for all curative diabetes research is an effective long-lasting blood glucose normalisation and stabilisation for both type I and type II diabetic patients, at levels comparable to those achieved by intensive insulin therapy in the Diabetes Control and Complications Trial (DCCT). Despite improvements in insulin pharmaceutical efficacy and delivery methods, this approach still has major limitations, significantly impacting on patients’ quality of life.

Scope: Proposals should develop one or more functional biomaterials for the long-term clinical efficacy of transplanted pancreatic islets, and the safe and reliable harvesting of cells from identified source(s), which facilitate highly sensitive identification/screening and sorting of isolated cells; allow for easy handling and safe storage of isolated cells and/or tissue engineering constructs; provide immunoprotection and facilitate construct grafting in target anatomical areas; as well as clinically-reflective in vitro models useful as indicators of long-term in vivo behaviour. A realistic endpoint of the project should be described and justified. Proposals should generate comprehensive pre-clinical data and after completion of the project, the material should be in an optimal position for entering clinical trials or, in case of innovative diagnostic tools, for the validation stage. Preclinical regulatory matters, including the investigational medicinal product dossier (IMPD), should be completed or taken to an advanced stage. Experimental protocols should be planned in accordance with the provisions of the Advanced Therapy Medicinal Products (ATMP) Regulation. Also, the standardisation and manufacturing process can be addressed including up-scaling and good manufacturing practice (GMP).

For this topic, proposals should include an outline of the initial exploitation and business plans, which will be developed further in the proposal project.

Activities expected to focus on Technology Readiness Level 5.

The Commission considers that proposals requesting a contribution from the EU between EUR 6 and 8 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

Expected impact:

                Improvement of the quality of life of both Type I and Type II patients with diabetes mellitus;

                Reduced direct and indirect costs linked to the disease and its treatment, and wide availability of treatments; 

                Implementation of relevant objectives of the European Innovation Partnership on Active and Healthy Ageing (COM (2012)83).

Type of action: Research & Innovation Actions

[1] A recent study found that the total cost of diabetes (direct and indirect) is estimated to exceed €188 billion in 5 study countries (UK, Spain, Italy, France, Germany) of the EU alone. The absolute number of diabetics in the EU27 is expected to rise from approximately 33 million in 2010 to 38 million in 2030.