Objective
Stroke is the second leading cause of death in the world population. When not fatal, stroke often results in disability, due to motor and cognitive impairments, and secondary health problems affecting not only patients but also their families.
Building on emerging preclinical and pilot clinical evidences, RESSTORE will focus on the clinical assessment of regenerative cell therapy to improve stroke recovery and patients quality of life. RESSTORE European multicentre randomised phase IIb will explore, for the first time, the efficacy (functional recovery) and safety of intravenous infusion of allogenic adipose tissue derived mesenchymal stem cells (ADMSCs) in 400 stroke patients. Therapeutic effects of ADMSCs will be assessed and monitored in patients using clinical rating scales, multimodal MRI and novel blood biomarkers. Additionally, the societal value and cost-effectiveness of ADMSCs-based regenerative therapy will be evaluated through health economics and predictive in silico simulations. Complementary ancillary animal studies will support the clinical trial by defining i) if the treatment response can be further enhanced by intensive rehabilitation, ii) the contribution of co-morbidities and iii) the mechanism(s) underlying the therapeutic effect.
The European regenerative therapy capacities (France, Spain, Finland, United Kingdom and Czech Republic), developed in RESSTORE will cover the full value chain in the field (large scale GMP cell production, clinical testing, biomarkers discovery, understanding of the restoring mechanisms, modelling, biobanking, economic studies, exploitation and communication plan). RESSTORE will thus surely contribute, together with the workforce trained in the context of the programme, to improve its public and private (SME) competitiveness and increase the attractiveness of Europe as a reference location to develop and clinically assess new innovative therapeutic options for brain diseases.
Field of science
- /medical and health sciences/basic medicine/physiology/pathophysiology
- /medical and health sciences/clinical medicine/endocrinology/diabetes
- /social sciences/economics and business/economics/health economics
- /medical and health sciences/basic medicine/neurology/stroke
- /medical and health sciences/medical biotechnology/cells technologies/stem cells
- /natural sciences/computer and information sciences/software/software development
- /medical and health sciences/clinical medicine/physiotherapy
- /natural sciences/mathematics/applied mathematics/mathematical model
- /social sciences/political science/government systems
- /medical and health sciences/basic medicine/immunology
Programme(s)
Call for proposal
H2020-PHC-2015-single-stage_RTD
See other projects for this call
Funding Scheme
RIA - Research and Innovation actionCoordinator
38058 Grenoble
France
Participants (28)
28020 Madrid
38700 La Tronche
656 91 Brno
41071 Sevilla
G12 8QQ Glasgow
70211 Kuopio
93210 La Plaine Saint Denis
33100 Tampere
48160 Derio Bizkaia
70700 Kuopio
75654 Paris
08035 Barcelona
69002 Lyon
95021 Cergy Pontoise Cedex
69009 Lyon
69003 Lyon
25030 Besancon Cedex
75000 Paris
31052 Toulouse Cedex 3
33404 Talence
14033 Caen Cedex 5
42002 Soria
08025 Barcelona
45007 Toledo
15703 Santiago De Compostela
17190 Girona
33521 Tampere
75014 Paris