Evidence map›Paper›PMID 31501122›Full record

ArticleBMJ open2019

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.

Barbara Willekens, Silvia Presas-Rodríguez, M J Mansilla, Judith Derdelinckx, Wai-Ping Lee, Griet Nijs, Maxime De Laere, Inez Wens, Patrick Cras, Paul Parizel and 25 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 72 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
72citing papers in PubMed, 1 pooled it
4.3field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02618902 phase1completednot on this map

A "negative"dendritic Cell-based Vaccine for the Treatment of Multiple Sclerosis: a First-in-human Clinical Trial

TypeinterventionalSponsorUniversity Hospital, AntwerpRan2017 to 2022Enrolled9ConditionsMultiple SclerosisArmstolerogenic dendritic cells (tolDC)
NCT02903537 phase1unknown statusnot on this map

Tolerance-Induction With Dendritic Cells Treated With Vitamin-D3 and Loaded With Myelin Peptides, in Multiple Sclerosis Patients (TOLERVIT-MS)

TypeinterventionalSponsorFundació Institut Germans Trias i PujolRan2017 to 2023Enrolled16ConditionsMultiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic ProgressiveArmsAutologous VitD3 tolerogenic monocyte-derived dendritic cells loaded with a pool of myelin peptides (tolDC-VitD3), Interferon-beta
3 · Its place in the literature

Who cites it

72 citing papers in PubMed, 1 synthesis or guideline pooled it, 97 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Immune reconstitution and tolerance-inducing therapies as promising therapeutic approaches in multiple sclerosis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026
    Review
  4. Review
  5. Article
  6. Article
  7. Review
  8. Article
  9. Review
  10. Review
  11. Review
  12. Article
  13. Article
  14. Article
  15. Multiple sclerosis: molecular pathogenesis and therapeutic intervention.Signal transduction and targeted therapy · 2025
    Review
  16. Article
  17. Review
  18. Review
  19. The Biology of Dendritic Cells: In Health and Disease.Advances in experimental medicine and biology · 2025
    Review
  20. Article

12 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

35 authors at 9 institutions in 4 countries.

Barbara Willekens *Department of Neurology, University Hospital Antwerp, Edegem, Belgium.ORCID 0000-0002-5212-8837
Silvia Presas-Rodríguez *Multiple Sclerosis Unit, Department of Neurosciences, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.
M J MansillaDivision of Immunology, LCMN, Hospital Universitario Germans Trias i Pujol and Research Institute, Badalona, Spain.
Judith DerdelinckxDepartment of Neurology, University Hospital Antwerp, Edegem, Belgium.
Wai-Ping LeeCenter for Cell Therapy and Regenerative Medicine, University Hospital Antwerp, Edegem, Belgium.
Griet NijsCenter for Cell Therapy and Regenerative Medicine, University Hospital Antwerp, Edegem, Belgium.
Maxime De LaereLaboratory of Experimental Hematology, Vaccine & Infectious Disease Institute (VAXINFECTIO), University of Antwerp Faculty of Medicine and Health Sciences, Wilrijk, Belgium.
Inez WensLaboratory of Experimental Hematology, Vaccine & Infectious Disease Institute (VAXINFECTIO), University of Antwerp Faculty of Medicine and Health Sciences, Wilrijk, Belgium.
Patrick CrasDepartment of Neurology, University Hospital Antwerp, Edegem, Belgium.
Paul ParizelDepartment of Radiology, University Hospital Antwerp, Edegem, Belgium.
Wim Van HeckeIcometrix NV, Leuven, Belgium.
Annemie RibbensIcometrix NV, Leuven, Belgium.
Thibo BillietIcometrix NV, Leuven, Belgium.
Geert AdamsC-Clear Partners, Mortsel, Belgium.
Marie-Madeleine CouttenyeDepartment of Nephrology, University Hospital Antwerp, Edegem, Belgium.
Juan Navarro-BarriusoDivision of Immunology, LCMN, Hospital Universitario Germans Trias i Pujol and Research Institute, Badalona, Spain.
Aina Teniente-SerraDivision of Immunology, LCMN, Hospital Universitario Germans Trias i Pujol and Research Institute, Badalona, Spain.
Bibiana Quirant-SánchezDivision of Immunology, LCMN, Hospital Universitario Germans Trias i Pujol and Research Institute, Badalona, Spain.
Ascensión Lopez-Diaz de CerioHaematology-Cell Therapy Area, clinica universidad de navarra, Pamplona, Spain.
Susana InogésHaematology-Cell Therapy Area, clinica universidad de navarra, Pamplona, Spain.
Felipe ProsperHaematology-Cell Therapy Area, clinica universidad de navarra, Pamplona, Spain.
Anke KipLygature, Utrecht, The Netherlands.
Herman VerheijLygature, Utrecht, The Netherlands.
Catharina C GrossDepartment of Neurology, University Hospital Munster, Munster, Germany.
Heinz WiendlDepartment of Neurology, University Hospital Munster, Munster, Germany.
Marieke Sm Van HamDepartment of Immunopathology, Sanquin Research, Amsterdam, The Netherlands.
Anja Ten BrinkeDepartment of Immunopathology, Sanquin Research, Amsterdam, The Netherlands.
Ana Maria BarriocanalClinical Research Polyvalent Unit, Clinial Trial Unit-Spanish Clinical Research Network, Germans Trias i Pujol Health Sciences Research Institute, Badalona, Spain.
Anna Massuet-VilamajóInstitut de Diagnòstic per la Imatge, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.
Niel HensInteruniversity Institute for Biostatistics and statistical Bioinformatics (I-BioStat), Universiteit Hasselt, Hasselt, Belgium.
Zwi BernemanLaboratory of Experimental Hematology, Vaccine & Infectious Disease Institute (VAXINFECTIO), University of Antwerp Faculty of Medicine and Health Sciences, Wilrijk, Belgium.
Eva Martínez-CáceresDivision of Immunology, LCMN, Hospital Universitario Germans Trias i Pujol and Research Institute, Badalona, Spain.
Nathalie Cools *Laboratory of Experimental Hematology, Vaccine & Infectious Disease Institute (VAXINFECTIO), University of Antwerp Faculty of Medicine and Health Sciences, Wilrijk, Belgium nathalie.cools@uza.be cramot@gmail.com.
Cristina Ramo-Tello *Multiple Sclerosis Unit, Department of Neurosciences, Hospital Universitari Germans Trias i Pujol, Badalona, Spain nathalie.cools@uza.be cramot@gmail.com.
RESTORE consortium
University of Antwerp · BEUniversitat Autònoma de Barcelona · ESAntwerp University Hospital · BEClinica Universidad de Navarra · ESHospital Universitari Germans Trias i Pujol · ESIcometrix (Belgium) · BELygature · NLSanquin · NLUniversity of Münster · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionBased 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. TRIAL REGISTRATION NUMBERS: NCT02618902 and NCT02903537; EudraCT numbers: 2015-002975-16 and 2015-003541-26.

Indexed as

Immune ToleranceInjections, IntradermalLymph NodesAutoantigensClinical Trials, Phase I as TopicDendritic CellsHumansMultiple SclerosisTreatment OutcomeAutoantigensclinical trialsimmunologymagnetic resonance imagingmultiple sclerosis

Identifiers

PMID31501122
PMCPMC6738722
OpenAlexW2972621494

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.