Stem cells from amniotic fluid tested for progressive MS – but trial pulled
NCT ID NCT06841068
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 However, the study was withdrawn before any participants were enrolled, so no results are available.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- This trial was withdrawn before enrolling any participants, so no data exist.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 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: * 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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a blood pressure pill slow MS disability?
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- Could a simple injection replace an IV for MS treatment?
- Could a common supplement fight fatigue in progressive MS?