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Agency: European Commission | Branch: H2020 | Program: RIA | Phase: PHC-15-2015 | Award Amount: 6.34M | Year: 2015

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.

Boissel J.-P.,Novacare SAS | Boissel J.-P.,Novadiscovery SAS | Boissel J.-P.,CNRS Biometry and Evolutionary Biology Laboratory | Boissel J.-P.,University Claude Bernard Lyon 1 | And 12 more authors.
Personalized Medicine | Year: 2011

Although personalized medicine has been a subject of research and debate in recent years, it has been underused in medical practice, except in some cancers. We believe that the main reason for the gap between the potential of personalized medicine and its use in daily medical practice can be explained by the lack of an appropriate tool to facilitate the use of biomarker values in a doctors decision-making process. We propose that the effect model could form the basis of such a tool. © 2011 Future Medicine Ltd.

Agency: European Commission | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2012.2.1.2-1 | Award Amount: 3.93M | Year: 2012

Lung transplantation (LT) is the standard of care for selected patients with chronic respiratory failure. Chronic lung allograft dysfunction (CLAD) (i.e. Bronchiolitis obliterans syndrome (BOS) and Restrictive Allograft Syndrome (RAS)) represents a major health risk for LT recipients, requiring the use of heavy treatments and possible retransplantation. Observed in almost 50% of patients after 5 years post LT, it is currently impossible to predict the appearance of CLAD before the onset of first symptoms. This project aims to develop the SysCLAD model which will allow to predict, within the 1st year post LT, the recipients at risk of developing CLAD by 3 years post LT. Building upon available data from the cohort of lung transplantation (COLT, recruited since mid-2009), this project will integrate new LT recipients to form the European cohort of lung transplantation (ECOLT). The SysCLAD prediction tool will be based on a mathematical model developed through a system biology approach integrating both clinical and biological data collected from a total of 400 LT recipients. The model will be validated on the first 200 LT recipients (3 years follow-up at project start) and refined using the new set of 200 LT data with 3 years follow-up by 2014. The aim is to identify and validate the signature of CLAD both at the clinical and molecular levels to allow for an early recognition and specific interventions in patients at risk of CLAD. The implementation of the model is expected to significantly improve the cost-effectiveness of post-LT treatments, limit the risk of graft rejection in LT recipients and, ultimately lead to an improved quality of life and a prolonged life expectancy of patients following LT. Finally, the SysCLAD model holds further great promises in the context of other chronic bronchial inflammatory diseases of major incidence such as severe asthma and Chronic Obstructive Pulmonary Disease (COPD) to predict decline in lung function.

Boissel J.-P.,Novadiscovery SAS | Auffray C.,University of Lyon | Noble D.,University of Oxford | Hood L.,Institute for Systems Biology | Boissel F.-H.,Novadiscovery SAS
CPT: Pharmacometrics and Systems Pharmacology | Year: 2015

While there is widespread consensus on the need both to change the prevailing research and development (R&D) paradigm and provide the community with an efficient way to personalize medicine, ecosystem stakeholders grapple with divergent conceptions about which quantitative approach should be preferred. The primary purpose of this position paper is to contrast these approaches. The second objective is to introduce a framework to bridge simulation outputs and patient outcomes, thus empowering the implementation of systems medicine. © 2015 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

Kahoul R.,Novadiscovery SAS | Kahoul R.,CNRS Biometry and Evolutionary Biology Laboratory | Gueyffier F.,CNRS Biometry and Evolutionary Biology Laboratory | Amsallem E.,CETAF | And 5 more authors.
Journal of the Royal Society Interface | Year: 2014

Healthcare authorities make difficult decisions about how to spend limited budgets for interventions that guarantee the best cost-efficacy ratio.We propose a novel approach for treatment decision-making, OMES-in French: Objectif thérapeutique Modèle Effet Seuil (in English: Therapeutic Objective- Threshold-Effect Model; TOTEM). This approach takes into consideration results from clinical trials, adjusted for the patients' characteristics in treatment decision-making. We compared OMES with the French clinical practice guidelines (CPGs) for the management of dyslipidemia with statin in a computergenerated realistic virtual population, representing the adult French population, in terms of the number of all-cause deaths avoided (number of avoided events: NAEs) under treatment and the individual absolute benefit. The total budget was fixed at the annual amount reimbursed by the French social security for statins. With the CPGs, the NAEs was 292 for an annual cost of 122.54ME compared with 443 with OMES. For a fixed NAEs, OMES reduced costs by 50% (60.53M€yr-1). The results demonstrate that OMES is at least as good as, and even better than, the standard CPGs when applied to the same population. Hence the OMES approach is a practical, useful alternative which will help to overcome the limitations of treatment decision-making based uniquely on CPGs. © 2014 The Author(s) Published by the Royal Society. All rights reserved.

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