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.
Fields of science
Not validated
Not validated
- medical and health sciencesbasic medicinephysiologypathophysiology
- medical and health sciencesclinical medicinephysiotherapy
- medical and health sciencesmedical biotechnologycells technologiesstem cells
- medical and health sciencesbasic medicineneurologystroke
- social scienceseconomics and businesseconomicshealth economics
Keywords
Programme(s)
Funding Scheme
RIA - Research and Innovation actionCoordinator
38058 Grenoble
France
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Participants (28)
28046 MADRID
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38700 La Tronche
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602 00 Brno
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41071 Sevilla
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G12 8QQ Glasgow
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70211 KUOPIO
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93210 La Plaine Saint Denis
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33100 Tampere
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48160 Derio Bizkaia
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
70700 Kuopio
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75654 Paris
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08035 Barcelona
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69002 Lyon
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95021 Cergy Pontoise Cedex
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69009 Lyon
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
69003 Lyon
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
25030 BESANCON CEDEX
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75012 Paris
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31052 Toulouse Cedex 3
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33404 Talence
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14033 Caen Cedex 5
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42002 Soria
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08041 Barcelona
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45007 Toledo
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15703 Santiago De Compostela
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17190 Girona
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33521 Tampere
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75014 Paris
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