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
Willekens, Barbara (University of Antwerp. Laboratory of Experimental Hematology. Vaccine and Infectious Disease Institute)
Presas-Rodríguez, Silvia (Universitat Autònoma de Barcelona. Departament de Medicina)
Mansilla Lopez, Maria Jose (Universitat Autònoma de Barcelona. Departament de Biologia Cel·lular, de Fisiologia i d'Immunologia)
Derdelinckx, Judith (University of Antwerp. Laboratory of Experimental Hematology. Vaccine and Infectious Disease Institute)
Lee, Wai-Ping (University Hospital Antwerp (Bèlgica))
Nijs, Griet (University Hospital Antwerp (Bèlgica))
De Laere, Maxime (University of Antwerp. Laboratory of Experimental Hematology. Vaccine and Infectious Disease Institute)
Wens, Inez (University of Antwerp . Laboratory of Experimental Hematology. Vaccine and Infectious Disease Institute)
Cras, Patrick (University Hospital Antwerp (Bèlgica))
Parizel, Paul (University Hospital Antwerp (Bèlgica))
Van Hecke, Wim (Icometrix NV)
Ribbens, Annemie (Icometrix NV)
Billiet, Thibo (Icometrix NV)
Adams, Geert (C-Clear Partners)
Couttenye, Marie-Madeleine (University Hospital Antwerp (Bèlgica))
Navarro-Barriuso, Juan (Universitat Autònoma de Barcelona. Departament de Biologia Cel·lular, de Fisiologia i d'Immunologia)
Teniente Serra, Aina (Universitat Autònoma de Barcelona. Departament de Biologia Cel·lular, de Fisiologia i d'Immunologia)
Quirant, Bibiana (Universitat Autònoma de Barcelona. Departament de Biologia Cel·lular, de Fisiologia i d'Immunologia)
Lopez-Diaz De Cerio, Ascensión (Clínica Universidad de Navarra)
Inogés, Susana (Clínica Universidad de Navarra)
Prosper, Felipe (Clínica Universidad de Navarra. Centro de Investigación Médica Aplicada)
Kip, Anke (Lygature Utrecht)
Verheij, Herman (Lygature Utrecht)
Gross, Catharina C. (University of Munster. Department of Neurology)
Wiendl, Heinz (University of Munster. Department of Neurology)
Van Ham, Marieke (University of Amsterdam. Academic Medical Centre-AMC)
Ten Brinke, Anja (University of Amsterdam. Academic Medical Centre-AMC)
Barriocanal, Ana María (Universitat Autònoma de Barcelona. Departament de Farmacologia, de Terapèutica i de Toxicologia)
Massuet-Vilamajó, Anna (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Hens, Niel (University of Antwerp. Centre for Health Economic Research and Modelling Infectious Diseases)
Berneman, Zwi (University of Antwerp. Center for Cell Therapy and Regenerative Medicine)
Martínez Cáceres, Eva María (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Cools, Nathalie (University Hospital Antwerp (Bèlgica))
Ramo-Tello, Cristina (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)

Fecha:	2019
Resumen:	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.
Ayudas:	European Commission 779316
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Publicado en:	BMJ open, Vol. 9, Issue 9 (July 2019) , art. e030309, ISSN 2044-6055

DOI: 10.1136/bmjopen-2019-030309
PMID: 31501122

11 p, 861.1 KB

El registro aparece en las colecciones:
Documentos de investigación > Documentos de los grupos de investigación de la UAB > Centros y grupos de investigación (producción científica) > Ciencias de la salud y biociencias > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
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