Leistungen
Adverse events will be summarized by presenting for each cohort, the number and proportion of patients having any adverse event. All AE and special reporting situations, whether serious or non-serious, occurring during the study will be reported to the data and safety monitoring board by study-site personnel within 24 hours of their knowledge of the event. The investigators will report these events to the regulatory authorities and the independent ethics committee that approved the protocol.
Certificates of clinical trainingWe 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.
Report on the overall safety and tolerability of tolDC therapyThe overall goal of the ReSToRe project is to assess the safety and tolerability and demonstrate first proof-of-concept of administering clinical-grade vitamin D3-treated tolDC loaded with myelin-derived peptides via different administration routes to treat a well-defined subpopulation of MS patients. At this timepoint, assessment of safety and tolerability will be possible based on data gathered through standardized clinical, radiological and immunological evaluation of tolDC therapy in MS.
Stakeholder committee evaluation report (2)A second stakeholder committee evaluation report will be prepared by month 42
Stakeholder committee evaluation report (1)Timely communication among the various stakeholders is critical to ensure patient safety in clinical trials. In order to spread awareness and information about the project and its results beyond the research community with the public as a whole, we envisage to install a stakeholder committee that will consist of experts from major interest groups that are interested in receiving exposure to the project and are willing to exchange knowledge relating to ReSToRe’s communication and operation, i.e. representatives from patient organizations (including patients and their families), the investigators, institutional review board/ethics committee, and the scientific, medical and business community. The stakeholder committee will be informed regularly per e-mail and in organized meetings about the progress of the project and will supervise the research and the dissemination material. On the other hand, the members of the stakeholder committee will provide the project with an opportunity to receive external validation of approach and results, whilst supporting networks and associations thereby amplifying the outreach of ReStoRe’s dissemination plan. By involving the stakeholder committee from the start to the end of the project, we will ensure a high quality level of all actions.
Plans for dissemination and exploitation of the resultsThe applicants strongly believe in collaboration and dissemination of knowledge keeping in mind the patients 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
Stakeholder committee evaluation report (3)A final stakeholder committee evaluation report will be prepared by month +60
Report on overall study monitoringAlthough data entry necessarily is a local responsibility for each participating center in order to respect the protection of the patient's identity, study monitoring by an ISO-certified specialised company or (academic) CRO will guarantee coherent clinical data acquisition and harmonisation at all sites.
Report on clinical trial design and voluntary harmonization procedure"All documents needed for regulatory and ethical approval to proceed to the second stage of the outlined clinical trials will be submitted to the CTFG in order to obtain a harmonised assessment for the proposed clinical trial application. As a result we anticipate to obtain a single opinion and one ""all approvals package""."
Reporting of adverse effects of intradermal vs. intranodal administration of tolDC to investigators, data safety monitoring board and regulatory authoritiesWe anticipate timely, accurate, and complete reporting and analysis of safety information. Adverse events will be summarised by presenting for each cohort, the number and proportion of patients having an adverse event.
Documentation of adverse effects in the third cohort receiving the highest dose of peptide-loaded tolDCAdverse events will be summarized by presenting for each cohort the number and proportion of patients having any adverse event All AE and special reporting situations whether serious or nonserious occurring during the study will be reported to the data and safety monitoring board by studysite personnel within 24 hours of their knowledge of the event The investigators will report these events to the regulatory authorities and the independent ethics committee that approved the protocol
Documentation of adverse effects in the second cohort receiving the intermediate dose of peptide-loaded tolDCAdverse events will be summarized by presenting for each cohort, the number and proportion of patients having any adverse event. All AE and special reporting situations, whether serious or non-serious, occurring during the study will be reported to the data and safety monitoring board by study-site personnel within 24 hours of their knowledge of the event. The investigators will report these events to the regulatory authorities and the independent ethics committee that approved the protocol.
A data management plan describing the data management life cycle for the data to be collected processed andor 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 andor 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 sharedmade open How will data be curated and preserved
ReSToRe will create and publish the public dissemination material via its website, project brochures, newsletters (twice a year), etc.. An update will be provided together with the second report on status of posting results.
Dissemination materialsReSToRe will create and publish the public dissemination material via its website, project brochures, newsletters (twice a year), etc.. An update will be provided together with the first report on status of posting results.
Dissemination materials (3)ReSToRe will create and publish the public dissemination material via its website, project brochures, newsletters (twice a year), etc.. An update will be provided together with the final report on status of posting results.
Project website, including internal section for partnersAs 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.
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.
Assessment of effect of safety and clinical outcome measures following administration of peptide-loaded tolDCHaving completed the safety and proof-of-concept comparison of intradermal vs. intranodal routes of administration, at this point, we will be able to assess the safety profile and clinical effects of peptide-loaded tolDC treatment in MS.
Demonstration of maximum tolerated dose of tolDCBy month 39, results of the dose-escalation study (WP3) will allow the identification of the maximum tolerated dose of tolDC.
In order to anticipate problems with patient recruitment, patient inclusion will be closely followed during the project and risk-mitigation measures are in place when needed.
Veröffentlichungen
Autoren:
María José Mansilla; Iñigo González-Larreategui; Neus Figa-Martín; Jaume Barallat; Federico Fondelli; Ares Sellés-Rius; Bibiana Quirant-Sánchez; Aina Teniente-Serra; Eva Martínez-Cáceres
Veröffentlicht in:
International Journal of Molecular Sciences, Ausgabe 7, 2021, ISSN 1422-0067
Herausgeber:
Multidisciplinary Digital Publishing Institute (MDPI)
DOI:
10.3390/ijms22147363
Autoren:
Inez Wens; Ibo Janssens; Judith Derdelinckx; Megha Meena; Barbara Willekens; Nathalie Cools
Veröffentlicht in:
International Journal of Molecular Sciences, Ausgabe 1, 2021, ISSN 1422-0067
Herausgeber:
Multidisciplinary Digital Publishing Institute (MDPI)
DOI:
10.3390/ijms22147536
Autoren:
Barbara Willekens; Inez Wens; Kristien Wouters; Patrick Cras; Nathalie Cools
Veröffentlicht in:
Autoimmunity reviews, Ausgabe 2, 2021, ISSN 1568-9972
Herausgeber:
Elsevier BV
DOI:
10.1016/j.autrev.2021.102873
Autoren:
Daniela Di Blasi, Iris Claessen, Annelies W. Turksma, Josine van Beek, Anja ten Brinke
Veröffentlicht in:
Journal of Immunological Methods, Ausgabe 487, 2020, Seite(n) 112907, ISSN 0022-1759
Herausgeber:
Elsevier BV
DOI:
10.1016/j.jim.2020.112907
Autoren:
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
Veröffentlicht in:
Frontiers in Immunology, Ausgabe 10, 2019, ISSN 1664-3224
Herausgeber:
Frontiers Media S.A
DOI:
10.3389/FIMMU.2019.00181
Autoren:
M. J. Mansilla, S. Presas-Rodríguez, A. Teniente-Serra, I. González-Larreategui, B. Quirant-Sánchez, F. Fondelli, N. Djedovic, D. Iwaszkiewicz-Grześ, K. Chwojnicki, Đ. Miljković, P. Trzonkowski, C. Ramo-Tello, E. M. Martínez-Cáceres
Veröffentlicht in:
Cellular & Molecular Immunology, Ausgabe 18/6, 2021, Seite(n) 1353-1374, ISSN 1672-7681
Herausgeber:
Nature Publishing Group
DOI:
10.1038/s41423-020-00618-z
Autoren:
Barbara Willekens, Silvia Presas-Rodríguez, MJ Mansilla, Judith Derdelinckx, Wai-Ping Lee, Griet Nijs, Maxime De Laere, Inez Wens, Patrick Cras, Paul Parizel, Wim Van Hecke, Annemie Ribbens, Thibo Billiet, Geert Adams, Marie-Madeleine Couttenye, Juan Navarro-Barriuso, Aina Teniente-Serra, Bibiana Quirant-Sánchez, Ascensión Lopez-Diaz de Cerio, Susana Inogés, Felipe Prosper, Anke Kip, Herman Ve
Veröffentlicht in:
BMJ Open, Ausgabe 9/9, 2019, Seite(n) e030309, ISSN 2044-6055
Herausgeber:
BMJ Publishing Group
DOI:
10.1136/bmjopen-2019-030309
Autoren:
Juan Navarro-Barriuso; Juan Navarro-Barriuso; María José Mansilla; María José Mansilla; Bibiana Quirant-Sánchez; Bibiana Quirant-Sánchez; Aina Teniente-Serra; Aina Teniente-Serra; Cristina Ramo-Tello; Eva M. Martínez-Cáceres; Eva M. Martínez-Cáceres
Veröffentlicht in:
Frontiers in Immunology, Ausgabe 1, 2021, ISSN 1664-3224
Herausgeber:
Frontiers Media S.A.
DOI:
10.3389/fimmu.2020.599623
Autoren:
Bibiana Quirant-Sánchez; María José Mansilla; Juan Navarro-Barriuso; Silvia Presas-Rodríguez; Aina Teniente-Serra; Federico Fondelli; Cristina Ramo-Tello; Eva Martínez-Cáceres
Veröffentlicht in:
Biomedicines, Vol 9, Iss 1758, p 1758 (2021), Ausgabe 8, 2021, ISSN 2227-9059
Herausgeber:
MDPI AG
DOI:
10.3390/biomedicines9121758
Autoren:
Juan Navarro-Barriuso, María José Mansilla, Bibiana Quirant-Sánchez, Alicia Ardiaca-Martínez, Aina Teniente-Serra, Silvia Presas-Rodríguez, Anja ten Brinke, Cristina Ramo-Tello, Eva M. Martínez-Cáceres
Veröffentlicht in:
Frontiers in Immunology, Ausgabe 10, 2019, ISSN 1664-3224
Herausgeber:
Frontiers in Immunology
DOI:
10.3389/fimmu.2019.01251
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