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COLOMBO Deliverable 6.3: Exploitation Plan
The aim of this document is to indicate how the results of COLOMBO can be exploited. The document does not only focus on the duration of the project, but also assesses the possibilities beyond the end at 31st of October 2015. A good reference for the exploitability of the COLOMBO results is the Technology Readiness Level (TRL), which is used in the document to indicate the maturity and marketability of the results. COLOMBO detection algorithms were developed for several situations. Data fusion between green phase duration and travel times from for instance navigation systems, can give useful estimates of traffic volumes. Full cooperative vehicles can give both queue estimates and traffic flow estimations and a work is being carried out on a separate traffic anomalies detection algorithm. Apart from the detection and traffic control algorithms, COLOMBO also developed and improved simulation tooling to facilitate the work in the project. The document also reviewed exploitation from a stakeholder perspective. Road operators and governments will profit from the availability of a lower cost alternative to current traffic control solutions both in initial investment and maintenance. Road users benefit from more efficient traffic control, resulting in lower travel time and fuel savings. Having a cooperative system in the vehicle also guarantees the queue the road user currently is in, has been detected by the controller. Therefore, cooperative vehicles are expected to have a lower average travel time. Traffic engineers, consultants, industry and researchers benefit from the (open source) tooling released by COLOMBO for their work.
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Tolerogenic dendritic cell-based treatment for multiple sclerosis (MS): a harmonised study protocol for two phase I clinical trials comparing intradermal and intranodal cell administration
Introduction Based on the advances in the treatment of multiple sclerosis (MS), currently available disease-modifying treatments (DMT) have positively influenced the disease course of MS. However, the efficacy of DMT is highly variable and increasing treatment efficacy comes with a more severe risk profile. Hence, the unmet need for safer and more selective treatments remains. Specifically restoring immune tolerance towards myelin antigens may provide an attractive alternative. In this respect, antigen-specific tolerisation with autologous tolerogenic dendritic cells (tolDC) is a promising approach. Methods and analysis Here, we will evaluate the clinical use of tolDC in a well-defined population of MS patients in two phase I clinical trials. In doing so, we aim to compare two ways of tolDC administration, namely intradermal and intranodal. The cells will be injected at consecutive intervals in three cohorts receiving incremental doses of tolDC, according to a best-of-five design. The primary objective is to assess the safety and feasibility of tolDC administration. For safety, the number of adverse events including MRI and clinical outcomes will be assessed. For feasibility, successful production of tolDC will be determined. Secondary endpoints include clinical and MRI outcome measures. The patients' immune profile will be assessed to find presumptive evidence for a tolerogenic effect in vivo. Ethics and dissemination Ethics approval was obtained for the two phase I clinical trials. The results of the trials will be disseminated in a peer-reviewed journal, at scientific conferences and to patient associations. ; A FACTT network (Cost Action) [BM1305]; EU Framework Program Horizon 2020; European Union's Horizon 2020 research and innovation program [779316]; applied biomedical research project of the Institute for the Promotion of Innovation by Science and Technology in Flanders [IWT-TBM 140191]; Platform for Clinical Research and Clinical Trial Units, Spanish Clinical Research Network, SCReN [PI11/02416, PI14/01175, PI16/01737, PT13/0002/0038]; Health Institute Carlos III -Subdireccion General de Evaluacion y Fomento de la Investigacion of the Spanish Ministry of Economy and Competitiveness; Fondo Europeo de Desarrollo Regional (FEDER)European Union (EU); Fundacio La Marato de TV3 [07/2410]; Sanofi Genzyme, Belgium; Research Foundation Flanders (FWO)FWO; Hospital Germans Trias i Pujol ('Germans Trias Talents 2016-2018'); University of Antwerp; Research Foundation FlandersFWO [FWO 1701919N]; Spanish Patient association 'Treball de Vida' (Associacio d'Afectats d'Esclerosi Multiple del Barcelones Nord i Maresme)
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