The RESSTORE project is funded by the European Commission under the Health Call “PHC-15-2015 - Clinical research on regenerative medicine” which calls for projects focusing on regenerative medicine therapies which are ready for clinical (in-patient) research”. RESSTORE has established a strong, multi-disciplinary, international group of experts to meet its objectives.
Stroke is a costly disease from human, family and societal perspectives. Stroke affects approximately 6 million people in the EU, with 1.1 million new cases every year. Despite spontaneous recovery, more than 50% of stroke patients have residual physical and/or cognitive impairment, causing a huge burden on the patients, their relatives (frequently taking the role of caregivers), and society. The total cost of disorders of the brain was estimated at €798 billion in 2010. Of that €64.1 billion is due to stroke mainly because of longterm special care and rehabilitation. Stroke burden is expected to increase due to aging of the population and diabetes, which is reaching an epidemic level. Thus, interventions to alleviate residual impairment are urgently needed to successfully treat stroke patients and reverse the natural trend of increase in the human, economic and social burden of stroke. RESSTORE will introduce a new therapeutic approach towards this extent and holds as a consequence promises to significantly reduce the socio-economic burden of stroke.
The network established in the context of RESSTORE will allow further developing and implementing innovative regenerative medicine translational capacities up to economic assessment for stroke in Europe while sustaining the growth and competitiveness of the partnering organisations. EFS (French Blood Company, pharmaceutical company) will develop GMP production capacities for ADMSC (Master Bank), while HISTOCELL (SME, Spain), as well as the Cell Therapy Units of Malaga Hospital (SAS) and of Tampere University (UTA) will implement GMP expansion processes to deliver the Working Banks (cell to be injected in patients). NOVADISCOVERY (SME), will developed a virtual population concept (validated in the context of lung transplantation – SYSCLAD FP7 project) to model the patient recovery capacity from stroke and by extension improve its competitiveness and visibility. In collaboration with ESSEC, NOVADISCOVERY will also allow assessing the cost-effectiveness (costbenefits) of RESSTORE therapeutic strategy. RESSTORE academic partners have unique expertise and experiences to be able to elucidate and investigate the physiological mechanisms underlying the restoring effects of cell therapy. Additionally, they will identify valuable biological surrogates (VHIR) and imaging biomarkers (UGA) which will constitute new powerful tools to monitor patient’s recovery along the rehabilitation process. Each reference clinical centres will reinforce their international recognition in the management (treatment and rehabilitation) of stroke. Finally, FINOVATIS (SME) will bring in its expertise to maximise the results impact and exploitation.
The cell-therapy capacities developed in the context of RESSTORE are covering the full value chain (GMP production, clinical testing, biomarkers discovery, understanding of the restoring mechanisms, modelling, biobanking, economic studies, exploitation and communication plan) in the field and thus will surely contribute, together with the workforce trained in the context of the programme, to increase the attractiveness of Europe as a reference location to develop and clinically assess new innovative therapeutic options. In addition, the knowledge generated by RESSTORE will inform the design of future clinical regenerative intervention studies for brain diseases and risk reduction, thus further to sustain the European leadership in regenerative medicine applied to brain diseases. Moreover, the evidence generated by RESSTORE can be utilized towards the formulation of effective public health policies with respect to stroke management. Finally, RESSTORE has the potential to prepare the ground for the P4 (predictive, preventive, personalized, and participatory medicine) medical revolution in the context of stroke by i) demonstrating the value, at the patient level, of P4 Medicine, ii) developing some infrastructures and technologies to support the large flow of data generated taking into account ethical regulations and iii) engaging with all stakeholders to demonstrate early the potential socio-economic impact of this paradigm shift.