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Stem cells from amniotic fluid tested for progressive MS – but trial pulled

NCT ID NCT06841068

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study aimed to test whether stem cells from amniotic fluid, injected into the spinal fluid, could safely help people with progressive multiple sclerosis (MS). The trial was designed for adults aged 18–60 with primary or secondary progressive MS. However, the study was withdrawn before any participants were enrolled, so no results are available.

What this could mean

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

Active substance
amniotic fluid stem cells (CD117-positive)
What this could lead to
If this therapy proves safe and effective, it could slow disability progression in people with progressive multiple sclerosis.
What could go wrong
This trial was withdrawn before enrolling any participants, so no data exist. Stem cell therapies for MS are still experimental and carry risks like infection or immune reactions.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Nov 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 to 60 years

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: * Adults aged 18-60 years. * Diagnosed with primary or secondary progressive MS according to the 2017 revised McDonald criteria. * Expanded Disability Status Scale (EDSS) of 3.0 to 8.0 with at least one functional scale that is not vision or sensory or brainstem or cognitive or bowel/bladder that is scoring 3.0 or greater. * Clinically stable as determined by their neurologist for the past 6 months. * On no disease-modifying therapy (DMT) for at least 6 months, or on the same DMT for at least 6 months before study entry. * Can give informed consent. * Women of child-bearing age must practice adequate contraception techniques in the eye of the investigator and continue to do so during the study period. * Must be a good candidate, known for compliance for example, in the opinion of the investigators. Exclusion Criteria: * Participation in another clinical trial within the last 30 days. * Severe allergic reactions to any component of the study treatments. * Significant comorbidities. * Active infections or malignancies. * History of a malignancy within the past two years except for skin cancer that has been excised and controlled with only surgical treatment, not requiring chemotherapy or radiotherapy. * Any medical condition that the investigator deems as unsuitable with therapy. * Prior organ, tissue, or stem cell transplant or cell therapy within 3 years of study entry * A diagnosis of a progressive neurological disorder other than multiple sclerosis. * Inability to have an MRI scan. * Inability to have a lumbar puncture, for example severe bleeding diathesis. * Pregnant or breastfeeding or intention to become pregnant during the study. * The results of the following laboratory results deemed suitable by the investigators: CBC with diff, CMP, INR, aPTT, Hepatitis C serology, HIV serology, RPR.

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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

  • Atrium Health

    Charlotte, North Carolina, 28204, United States

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