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Multiple Sclerosis, ProgressivePhase 1/2NCT06841068

Intrathecal Amniotic Fluid Stem Cells for Progressive Multiple Sclerosis

A Phase 1/2 study testing Amniotic fluid or placental CD117 stem cells in people with Multiple Sclerosis, Progressive, run by Wake Forest University Health Sciences at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

In this clinical trial, researchers are exploring a novel approach to delivering therapy directly into the spinal fluid, which surrounds and nourishes the brain and spinal cord. The study focuses on patients with progressive multiple sclerosis (MS), a form of the disease that leads to worsening disability without the… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Multiple Sclerosis, Progressive
What is being tested?
Amniotic fluid or placental CD117 stem cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Feb 2026to Nov 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Atrium Health

    Charlotte, North Carolina, 28204

Other trials in United States

About this study

Official title: A Phase I/II Trial of Intrathecal Delivery of Amniotic Fluid Stem Cells for Primary and Secondary Progressive Multiple Sclerosis

In this clinical trial, researchers are exploring a novel approach to delivering therapy directly into the spinal fluid, which surrounds and nourishes the brain and spinal cord. The study focuses on patients with progressive multiple sclerosis (MS), a form of the disease that leads to worsening disability without the typical relapses seen in other MS subtypes.

This investigational therapy involves the use of stem cells derived from amniotic fluid-the protective liquid surrounding a developing baby in the womb. To the best of the researchers' knowledge, these specific stem cells have never been tested in MS patients before. Amniotic fluid is ethically sourced from routine medical procedures during pregnancy, and similar stem cells can also be obtained from placentas that are typically discarded after childbirth.

Participants in the trial will receive multiple injections of these stem cells into their spinal fluid over the course of a year. Researchers will closely monitor for the safety of this therapy, as well as monitor the participants' walking ability and other neurological functions to assess potential improvements.

Being tested
Amniotic fluid or placental CD117 stem cells
Medical subject headings
Multiple Sclerosis, Chronic Progressive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Amniotic fluid or placental CD117 stem cellsBiological

    CD117 (c-Kit) positive stem cells, extracted from ethical fetal sources such as amniotic fluid and placental tissue.

Study groups in NCT06841068
Study groupRoleWhat they receive
Open label stem cell armExperimentalThe first 5 participants will receive 4 intrathecal injections of c-Kit stem cells at a dose of 25 x 106 cells per injection. The next 5 patients will receive 4 intrathecal injections of c-Kit stem cells at a dose of 50 x 106cells per injection. The next 10 patients will receive 4 intrathecal injections of c-Kit stem cells at a dose of 80 x 106cells per injection. Only if a dose is deemed safe by the investigators after 1 month of its first injection, will we advance to the next dose.
Receives: Biological: Amniotic fluid or placental CD117 stem cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

    The primary safety outcome will be the incidence of adverse events (AEs) and serious adverse events (SAEs) related to the treatment, including their severity and duration. Adverse events will be classified according to the NIH Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: From enrollment to the end of treatment at 12 months

Secondary outcomes (4)

  1. The Multiple Sclerosis Functional Composite (MSFC) score

    The Multiple Sclerosis Functional Composite (MSFC) is a three-part quantitative objective measure of neurologic function, measuring leg (timed 25-foot walk [25FTW] measured in seconds), arm (nine-hole peg test [9HPT] measured in seconds), and cognitive (three-second paced auditory serial addition test [PASAT3] measured in z-score) functions. The MSFC is a continuous scale that is a composite of the scores of its three parts. A change of 20% or more of the total score (the MSFC composite) or any of its individual component parts (25FTW, 9HPT, PASAT3) is considered clinically significant.

    Measured: From enrollment to the end of treatment at 12 months

  2. The Six-minute Walk Test

    The maximum distance walked in 6 minutes is measured. If the patient cannot complete the 6-minute walk then the measurement becomes the total time walked. A 20% change in the distance walked in 6 minutes for those who complete the 6-minute walk, or a 20% change in the total time walked for those who cannot, will be considered clinically significant.

    Measured: From enrollment to the end of treatment at 12 months

  3. The Expanded Disability Status Scale (EDSS)

    The Expanded Disability Status Scale (EDSS) score ranges from 0 to 10.0, with higher scores indicating a greater degree of disability.25 Participants will undergo EDSS assessments at baseline, 6 months, and 12 months. A reduction in EDSS score by 1 point for baseline scores ≤5.5 and by 0.5 points for baseline scores ≤6.0 will indicate a reduction in disability, and vice versa for disability progression.

    Measured: From enrollment to the end of treatment at 12 months

  4. The Multiple Sclerosis Quality of Life-54 (MSQoL-54)

    The Multiple Sclerosis Quality of Life-54 (MSQoL-54) is a health-related quality of life (HRQoL) questionnaire specifically designed for people with multiple sclerosis (MS). The MSQoL-54 generates 12 subscales and 2 composite scores.

    Scoring:

    1. Item scores range from 1 to 6, depending on the question format.
    2. Raw scores for each subscale are calculated by averaging item responses.
    3. Transformed scores: These raw scores are converted to a 0-100 scale, where 0 represents the worst possible health and 100 represents the best possible health.
    4. Composite scores for physical and mental health are calculated by averaging the relevant subscale scores.

    Interpretation:

    • Higher scores indicate better quality of life.
    • The physical health composite reflects mobility, energy, and physical pain.
    • The mental health composite covers emotional well-being, cognitive function, and social interaction.

    Measured: From enrollment to the end of treatment at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2025
  2. Study startFeb 2026 (estimated)
  3. Primary completionAug 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Why it stopped: lack of funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06841068
Sponsor's protocol ID
AFSC-PMS-001
Status last verified
Feb 2026
First submitted
16 Feb 2025
Last updated
6 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rosner M, Horer S, Feichtinger M, Hengstschlager M. Multipotent fetal stem cells in reproductive biology research. Stem Cell Res Ther. 2023 Jun 7;14(1):157. doi: 10.1186/s13287-023-03379-4.

    PubMed 37287077

  • Lassmann H. Pathogenic Mechanisms Associated With Different Clinical Courses of Multiple Sclerosis. Front Immunol. 2019 Jan 10;9:3116. doi: 10.3389/fimmu.2018.03116. eCollection 2018.

    PubMed 30687321

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Amniotic fluid or placental CD117 stem cells in people with Multiple Sclerosis, Progressive, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) (time frame: From enrollment to the end of treatment at 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06841068, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026; AzTrials last refreshed its copy on 27 Oct 2026.

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