Can Immune-Calming cells tame multiple sclerosis?
NCT ID NCT04530318
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2020
- Expected to finish
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Mar 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Hospital Clínic de Barcelona
Barcelona, 08036, Spain
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Hospital Moisés Broggi
L'Hospitalet de Llobregat, Barcelona, Spain
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Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
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Hospital de Sant Pau
Barcelona, Spain
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Hospital del Mar
Barcelona, Spain
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