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NEURONAL SELF-RENEWAL BY ANTIGEN-SPECIFIC TOLERIZATION IN MULTIPLE SCLEROSIS REINSTALLING THE BALANCE BETWEEN INFLAMMATION AND REGENERATION

Deliverables

Data Management Plan

A data management plan - describing the data management life cycle for the data to be collected, processed and/or generated by ReSToRe - will be drafted according to the Guidelines on FAIR Data Management in Horizon 2020. In brief, the data management plan will contain details on the incidental findings policy as well as detailed information on the procedures that will be implemented for data collection, storage, protection, retention, sharing, merging, reuse and/or destruction). The plan will also include a privacy impact assessment. In other words, items that will be addressed in the data management plan include: What data will be collected / generated? What standards will be used be generated? What data will be exploited? What data will be shared/made open? How will data be curated and preserved?

Certificates of clinical training

We aim at implementing standardized clinical monitoring procedures for peptide-loaded tolDC and training study staff on clinical monitoring to affirm harmonization and standardization will be started prior beginning the clinical trial. Prior to commencement of the clinical trial, P1 (UA), P2 (UZA) and P4 (ICS) will organize seminars for all personnel involved in the clinical trial, a specialized training program for neurologists on diagnosis, patient enrolment, correct documentation and data collection, samples collection and follow up.

Plans for dissemination and exploitation of the results

The applicants strongly believe in collaboration and dissemination of knowledge keeping in mind the patient’s best interests. Dissemination will be carried out as soon as possible with due regard to the interests of all partners. Dissemination and exploitation plans will be drafted following the requirements of the EC.

Training for all personnel involved in the clinical trial

Prior to commencement of the clinical trial, P1 (UA), P2 (UZA) and P4 (ICS) will organize seminars for all personnel involved in the clinical trial, a specialized training program for neurologists on diagnosis, patient enrolment, correct documentation and data collection, samples collection and follow up. Regarding set-up and support for standardized and centralized use of MRI (WP6), IcoMetrix (P7) will provide the MRI protocol, operation manuals for acquisition and upload and training of the centers for acquisition and data transfer.

Project website, including internal section for partners

As part of ReSToRe's dissimination strategy, a website will be set up to promote public dissimination of project activities and research results. A private section for partners will also be included.

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Publications

Ways Forward for Tolerance-Inducing Cellular Therapies- an AFACTT Perspective

Author(s): Anja ten Brinke, Marc Martinez-Llordella, Nathalie Cools, Catharien M. U. Hilkens, S. Marieke van Ham, Birgit Sawitzki, Edward K. Geissler, Giovanna Lombardi, Piotr Trzonkowski, Eva Martinez-Caceres
Published in: Frontiers in Immunology, Issue 10, 2019, ISSN 1664-3224
DOI: 10.3389/FIMMU.2019.00181

Beyond the Magic Bullet: Current Progress of Therapeutic Vaccination in Multiple Sclerosis

Author(s): Barbara Willekens, Nathalie Cools
Published in: CNS Drugs, Issue 32/5, 2018, Page(s) 401-410, ISSN 1172-7047
DOI: 10.1007/s40263-018-0518-4

Tolerogenic dendritic cell-based treatment for multiple sclerosis (MS): a harmonized study protocol for two phase I clinical trials comparing intradermal and intranodal cell administration

Author(s): Willekens B, Presas-Rodríguez, Mansilla M, Derdelinckx J, Lee W-P, Nijs G, De Laere M, Wens I, Cras P, Parizel PM, Van Hecke W, Ribbens A, Billiet T, Adams G, Couttenye M, Navarro-Barriuso J, Teniente-Serra A, Quirant-Sánchez B, López-Díaz de Cerio A, Inogés S, Prósper F, Kip A, Verheij H, Gross CC, Wiendl H, van Ham SM, ten Brinke A, Barriocanal AM, Massuet-Vilamajó A, Hens N, Berneman Z,
Published in: BMJ Open, Issue accepted for publication 23/7/2019, 2019, ISSN 2044-6055