Full metadata record
DC Field | Value | Language |
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dc.creator | Willekens, B. (Barbara) | - |
dc.creator | Presas-Rodríguez, S. (Silvia) | - |
dc.creator | Mansilla, M.J. (M. J.) | - |
dc.creator | Derdelinckx, J. (Judith) | - |
dc.creator | Lee, W.P. (Wai Ping) | - |
dc.creator | Nijs, G. (Griet) | - |
dc.creator | Laere, M. (Maxime) | - |
dc.creator | Wens, I. (Inez) | - |
dc.creator | Cras, P. (Patrick) | - |
dc.creator | Parizel, P. (Paul) | - |
dc.creator | Hecke, W. (Wim) van | - |
dc.creator | Ribbens, A. (Annemie) | - |
dc.creator | Billiet, T. (Thibo) | - |
dc.creator | Adams, G. (Geert) | - |
dc.creator | Couttenye, M.M. (Marie Madeliene) | - |
dc.creator | Navarro-Barriuso, J. (Juan) | - |
dc.creator | Teniente-Serra, A. (Aina) | - |
dc.creator | Quirant-Sánchez, B. (Bibiana) | - |
dc.creator | Lopez-Diaz-de-Cerio, A. (Ascensión) | - |
dc.creator | Inoges, S. (Susana) | - |
dc.creator | Prosper-Cardoso, F. (Felipe) | - |
dc.creator | Kip, A. (Anke) | - |
dc.creator | Verheij, H. (Herman) | - |
dc.creator | Gross, C.C. (Catharina C.) | - |
dc.creator | Wiendl, H. (Heinz) | - |
dc.creator | Ham, M. (Marieke) van | - |
dc.creator | Brinke, A.T. (Anja Ten) | - |
dc.creator | Barriocanal, A.M. (Ana Maria) | - |
dc.creator | Massuet-Vilamajó, A. (Anna) | - |
dc.creator | Hens, N. (Niel) | - |
dc.creator | Berneman, Z. (Zwi) | - |
dc.creator | Martínez-Cáceres, E. (Eva) | - |
dc.creator | Cools, N. (Nathalie) | - |
dc.creator | Ramo-Tello, C. (Cristina) | - |
dc.date.accessioned | 2022-06-14T06:42:53Z | - |
dc.date.available | 2022-06-14T06:42:53Z | - |
dc.date.issued | 2019 | - |
dc.identifier.citation | Willekens, B. (Barbara); Presas-Rodríguez, S. (Silvia); Mansilla, M.J. (M. J.); et al. "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". BMJ Open. 9, 2019, e030309 | es |
dc.identifier.issn | 2044-6055 | - |
dc.identifier.uri | https://hdl.handle.net/10171/63641 | - |
dc.description.abstract | Introductio: 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. | es_ES |
dc.description.sponsorship | This work was supported by positive discussion through the A FACTT network (Cost Action BM1305: www.afactt.eu). COST is supported by the EU Framework Program Horizon 2020. This RESTORE project has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement number 779316. Further support was provided by an applied biomedical research project of the Institute for the Promotion of Innovation by Science and Technology in Flanders (IWT-TBM 140191), by projects PI11/02416, PI14/01175,PI16/01737 and PT13/0002/0038 (Platform for Clinical Research and Clinical Trial Units, Spanish Clinical Research Network, SCReN), integrated in the Plan Nacional de I+D+I and co-supported by the Health Institute Carlos III - Subdirección General de Evaluación y Fomento de la Investigación of the Spanish Ministry of Economy and Competitiveness and the Fondo Europeo de Desarrollo Regional (FEDER), and project 07/2410 Fundació La Marato de TV3. Furthermore, the authors received research funding from Sanofi Genzyme, Belgium. Judith Derdelinckx holds a PhD fellowship from the Research Foundation Flanders (FWO). Dr Presas-Rodríguez is a neurologist who has received a grant of Hospital Germans Trias i Pujol ('Germans Trias Talents 2016-2018') to work on this project. Dr Willekens is a neurologist at the Antwerp University Hospital supported by a research fellowship (2016-2018) of the University of Antwerp to work on this project and she currently holds a clinical PhD fellowship from the Research Foundation Flanders (FWO 1701919N). Spanish Patient association 'Treball de Vida' (Associació d'Afectats d'Esclerosi Múltiple del Barcelonès Nord i Maresme) and patient Ana Mª Calvo Marsal have donated funding to the Hospital Germans Trias i Pujol MS Unit. | es_ES |
dc.language.iso | eng | es_ES |
dc.publisher | BMJ | es_ES |
dc.rights | info:eu-repo/semantics/openAccess | es_ES |
dc.subject | Multiple sclerosis (MS) | es_ES |
dc.subject | Disease-modifying treatments (DMT) | es_ES |
dc.subject | Severe risk profile | es_ES |
dc.subject | Tolerogenic dendritic cells (tolDC) | es_ES |
dc.title | 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 | es_ES |
dc.type | info:eu-repo/semantics/article | es_ES |
dc.description.note | This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/ licenses/by/4.0/ | es_ES |
dc.identifier.doi | 10.1136/bmjopen-2019-030309 | - |
dadun.citation.publicationName | BMJ Open | es_ES |
dadun.citation.startingPage | e030309 | es_ES |
dadun.citation.volume | 9 | es_ES |
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