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Tolerogenic Dendritic Cells as a Therapeutic Strategy for the Treatment of Multiple Sclerosis Patients (TOLERVIT-MS)

NCT02903537 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-07-07

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and tolerability of the intranodal administration of autologous monocyte-derived dendritic cells tolerised with Vitamin-D3 and pulsed with myelin peptides (tolDC-VitD3) in multiple sclerosis patients . To select the most appropriate regime for the development of future therapeutic trials.

To evaluate the preliminary proof of concept by clinical and/or radiological activity and immunological markers.

Conditions

  • Multiple Sclerosis, Relapsing-Remitting
  • Multiple Sclerosis, Chronic Progressive

Interventions

DRUG

Autologous VitD3 tolerogenic monocyte-derived dendritic cells loaded with a pool of myelin peptides (tolDC-VitD3)

Intranodal administration

DRUG

Interferon-beta

Subcutaneous administration interferon-beta

Sponsors & Collaborators

  • Clinica Universidad de Navarra, Universidad de Navarra

    collaborator OTHER

  • Fundació Institut Germans Trias i Pujol

    lead OTHER

Principal Investigators

  • Cristina Ramo, MD.PhD.Neurologist · Badalona Hospital Germans Trias i Pujol. Neurology service. Multiple Sclerosis department

  • Eva Martínez-Cáceres, MD.PhD.Immunology · Badalona Hospital Germans Trias i Pujol. Immunology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-06
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02903537 on ClinicalTrials.gov