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Cerebrovascular diseases are one of the most prevalent health care problems worldwide. Total European cost of brain disorders in 2010 was €798 billion of which €64.1 billion alone was related to stroke. In many cases, the result of stroke is a loss of independent living and secondary health problems affecting not only patients but also their families. Because of the aging population, stroke burden is likely to increase in future. Thus, novel restorative therapies are urgently needed. Emerging preclinical evidence suggest that mesenchymal stem cells (MSC) from various tissues are effective in enhancing functional recovery. 

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. 

The RESSTORE project will go beyond the state-of-the-art via:

  1. The creation of a European network including SMEs with large GMP production capacities (therapeutic cells) relevant for a multicentre clinical trial,
  2. The assessment of the efficacy and therapeutic time window in the first phase IIb study with a large number of stroke patients (n=400) by using both clinical rating scales and MRI imaging as outcome measures,
  3. The identification of MRI and blood biomarkers, which could be used to monitor stroke recovery and help in defining patient subgroups which will benefit from cell therapy in future studies,
  4. Research into underlying regenerative mechanisms, and safety in experimental models, which cannot be accomplished in patients and 5) development of state of the art clinical MRI analysis software and predictive system biology models (virtual population).