Intrathecal Amniotic Fluid Stem Cells for Progressive Multiple Sclerosis
Key facts
- Who runs it
- Wake Forest University Health Sciences
- Where
- Charlotte, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Phase
- Phase 1/2
- Started
- Feb 2026
- Expected to end
- Nov 2026
- Type of study
- Interventional
- Treatments tested
- Amniotic fluid or placental CD117 stem cells
- Record updated
- 6 February 2026
- Why it stopped
- lack of funding
Who can take part
- Age
- 18 years to 60 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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 take part
- Prior organ, tissue, or stem cell transplant or cell therapy within 3 years of study entry
- Severe allergic reactions to any component of the study treatments
- 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
- A diagnosis of a progressive neurological disorder other than multiple sclerosis
- Inability to have a lumbar puncture, for example severe bleeding diathesis
- The results of the following laboratory results deemed suitable by the investigators: CBC with diff, CMP, INR, aPTT, Hepatitis C serology, HIV serology, RPR
- Participation in another clinical trial within the last 30 days
- Significant comorbidities
- Inability to have an MRI scan
- Pregnant or breastfeeding or intention to become pregnant during the study
Where in United States
- Atrium HealthCharlotte, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
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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.
The group in the trial
- Open label stem cell armTreatment being tested
The 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.
Treatment: Amniotic fluid or placental CD117 stem cells
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase I/II Trial of Intrathecal Delivery of Amniotic Fluid Stem Cells for Primary and Secondary Progressive Multiple Sclerosis
- Record updated
- 6 February 2026