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Can Immune-Calming cells tame multiple sclerosis?

NCT ID NCT04530318

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial tests whether infusions of special immune cells (tolerogenic dendritic cells) can reduce brain lesions and relapses in people with relapsing-remitting multiple sclerosis. The 45 participants also take standard MS drugs. The study aims to see if this cell therapy is safe and effective at controlling disease activity.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tolerogenic dendritic cells (TolDec)
What this could lead to
If it works, this could point toward a way to calm the immune system and reduce MS relapses without strong side effects.
What could go wrong
This is a small Phase 2 trial, so results may not be conclusive. The treatment is still experimental, and there is a risk of side effects or no benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2020

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age between 18-65 years old. 2. Patients diagnosed with RRMS according to 2017 McDonald criteria. 3. MS disease duration \< 10 years. 4. Expanded disability status scale (EDSS) from 0 to \< 5.5. 5. Patients eligible to start or already are in on treatment with first line immunomodulatory treatment (interferon beta 1a, interferon beta 1b, glatiramer acetate, teriflunomide or dymethyl-fumarate). 6. Able to sign informed consent. 7. Women of child-bearing potential must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence. Exclusion Criteria: 1. Presence of a relapse or use of steroids 30 days prior to screening visit. 2. Concomitant use of any type of immunomodulatory / immunosuppressive therapy. 3. Use of previous immunosuppressive or cytotoxic therapy in the last 6 months. Use of previous alemtuzumab, cladribine or bone marrow or stem cell transplant at any time. 4. Patients unable or unwilling to undergo MRI scans. 5. Severe systemic diseases or history of cancer or hereditary familiar cancer. 6. Clinically relevant concomitant disease: cardiac, gastrointestinal, hepatic, pulmonary, neurological, renal or other major disease. 7. Impossibility to proceed to the leukapheresis (e.g. absence of peripheral venous access). 8. Pregnant or breastfeeding women. 9. Drug or alcohol abuse. 10. Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS or to test positive for HIV antibody at screening. 11. Ongoing known bacterial, viral or fungal infection (with the exception of onychomycosis and dermatomycosis), positive hepatitis B surface antigen or hepatitis C antibody tests at screening. 12. Patients with a known history of syphilis or tuberculosis or test positive for syphilis (positive rapid plasma reagin, RPR) or tuberculosis (positive skin test) at screening. Active or latent tuberculosis (TB). 13. Dementia or severe psychiatric, cognitive or behavioral problems or other comorbidity that may interfere with the compliance to the protocol. 14. Any other clinically relevant medical or surgical condition, which, in the opinion of the investigator, would put the subject at risk by participating in the study. 15. Participation in other experimental studies within the previous 90 days prior to screening visit.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hospital Clínic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Moisés Broggi

    L'Hospitalet de Llobregat, Barcelona, Spain

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, Spain

  • Hospital de Sant Pau

    Barcelona, Spain

  • Hospital del Mar

    Barcelona, Spain

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