NCT04530318

Dendritic Cells Therapy Combined With Immunomodulatory Treatment in Multiple Sclerosis

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Judit Pich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this project is to assess properly the clinical efficacy of TolDec therapy by imaging, clinical and surrogate end-points related with the activity of the disease.

Detailed description

Our working hypothesis is to make a combination therapy with low-moderate efficacy immunomodulatory drugs with the aim of increasing efficacy without causing serious adverse effects such as those associated with the available high-efficacy therapies. Cellular therapies represent a highly specific treatment aimed to target selective "pathogenic" cells subsets. Tol-Dec loaded with immunogenic peptides interacts with Ag-specific T lymphocytes inducing regulatory T cells without affecting other cell subsets leading to a antinflammatory shift of immunological responses.

Conditions

• Relapsing-Remitting Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	Autologous peripheral blood differentiated adult tolerogenic dendritic cells expanded	The infusion of the cells / placebo will take place at the Hospital Clínic de Barcelona (weeks 0, 2 and 4).
OTHER	Placebo	The infusion of the cells / placebo will take place at the Hospital Clínic de Barcelona (weeks 0, 2 and 4).

Timeline

• Start date: 2020-01-27
• Primary completion: 2025-09-09
• Completion: 2026-03-15
• First posted: 2020-08-28
• Last updated: 2026-02-19

Locations

5 sites across 1 country: Spain