Please use this identifier to cite or link to this item:
http://hdl.handle.net/1942/31444
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 | Authors: | Willekens, Barbara Presas-Rodriguez, Silvia Mansilla, M. J. Derdelinckx, Judith Lee, Wai-Ping Nijs, Griet De Laere, Maxime WENS, Inez Cras, Patrick Parizel, Paul Van Hecke, Wim Ribbens, Annemie Billiet, Thibo Adams, Geert Couttenye, Marie-Madeleine Navarro-Barriuso, Juan Teniente-Serra, Aina Quirant-Sanchez, Bibiana Lopez-Diaz de Cerio, Ascension Inoges, Susana Prosper, Felipe Kip, Anke Verheij, Herman Gross, Catharina C. Wiendl, Heinz Van Ham, Marieke (SM) Ten Brinke, Anja Maria Barriocanal, Ana Massuet-Vilamajo, Anna HENS, Niel Berneman, Zwi Martinez-Caceres, Eva Cools, Nathalie Ramo-Tello, Cristina Ooms, Naomi Smeets, Dirk Bock, Leone Groot, Denis Koot, Wim-Jan Boiten, Janwillem Janssen, Jorg Peelen, Sjaak Turksma, A. Vanlier, R. Rispens, T. DiBlasi, D. Claessen, Iris Puig-Domingo, M. Lagunas Vila, Laia Basanta Pons, David Astiasaran, Itziar Mata Rodriguez, Javier Albring, Antje Arnholdt, Jana |
Issue Date: | 2019 | Publisher: | BMJ PUBLISHING GROUP | Source: | BMJ open, 9 (9) (Art N° e030309) | Abstract: | 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. | Notes: | Cools, N (reprint author), Univ Antwerp, Fac Med & Hlth Sci, Vaccine & Infect Dis Inst VAXINFECTIO, Lab Expt Hematol, Antwerp, Belgium.; Cools, N; Ramo-Tello, C (reprint author), Hosp Badalona Germans Trias & Pujol, Dept Neurosci, Multiple Sclerosis Unit, Badalona, Spain.; Cools, N (reprint author), Univ Hosp Antwerp, Ctr Cell Therapy & Regenerat Med, Edegem, Belgium. nathalie.cools@uza.be; cramot@gmail.com |
Keywords: | multiple sclerosis;clinical trials;immunology;magnetic resonance imaging | Document URI: | http://hdl.handle.net/1942/31444 | ISSN: | 2044-6055 | e-ISSN: | 2044-6055 | DOI: | 10.1136/bmjopen-2019-030309 | ISI #: | WOS:000497787600267 | Rights: | Open access. 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/. | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2020 |
Appears in Collections: | Research publications |
Files in This Item:
File | Description | Size | Format | |
---|---|---|---|---|
e030309_full.pdf | Published version | 861.15 kB | Adobe PDF | View/Open |
SCOPUSTM
Citations
5
checked on Sep 2, 2020
WEB OF SCIENCETM
Citations
62
checked on Sep 12, 2024
Page view(s)
28
checked on Sep 7, 2022
Download(s)
12
checked on Sep 7, 2022
Google ScholarTM
Check
Altmetric
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.