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Can a Patient's own stem cells rewire the damage of progressive MS?

NCT ID NCT03822858

Disease control Sponsor: Tisch Multiple Sclerosis Research Center of New York Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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
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) This study
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This status has not been confirmed recently, so it may be out of date.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 Sep 25, 2026 · Last updated Sep 25, 2026

Summary

Researchers are providing an experimental treatment to people with progressive multiple sclerosis who cannot join a separate Phase II stem cell trial. The treatment uses the patient's own bone marrow cells, which are grown in the lab into neural progenitor cells and then injected into the spinal fluid. Participants receive three to five doses, each containing up to 10 million cells, spaced three months apart. The goal is to see whether this approach is safe and whether it can help with disability.

What this could mean

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

Active substance
autologous bone marrow-derived mesenchymal stem cell-derived neural progenitor cells
What this could lead to
If it works, this approach could offer a way to slow or repair damage in progressive MS, a form that current treatments struggle to control.
What could go wrong
This is an early access program, not a randomized trial, so it cannot prove the treatment works. The cells come from each patient, which makes the process complex, and injecting into the spinal fluid carries risks like infection or headache.

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.

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 70 years

Sex

Anyone

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: * Diagnosis of MS as defined by the McDonald criteria * Diagnosis of primary progressive or secondary progressive MS * Patients will be 18 years or older * Significant disability shown by an Expanded Disability Status Score (EDSS, \[5\]) ≥4.5 that was not acquired within the last 12 months \*(Patients with moderate to severe cerebellar dysfunction who have an EDSS of \<6.5 who are not eligible for our Ph II Version Date: 11/21/18 Version #4 9 study will be included. This is because EDSS scores are heavily related to muscle strength and not balance or coordination and most accurately reflect paraparesis. Also there are patients with MS who have disabling upper limb coordination dysfunction but EDSS scores of better than 6.5 who are not suitable for the Phase II study but may benefit from this therapy). * Stable disease state as evidenced by a lack of gadolinium-enhancing lesions on an MRI and by a stable MRI disease burden (number of T2 lesions and size of lesions) in the last six months and no significant change in EDSS (1 point or more) in the last 12 months * Does not qualify for the inclusion/exclusion criteria of our Phase II stem cell trial. For example, patients with EDSS \>6.5 or MS symptom onset and/or duration of disease \>15 years Exclusion Criteria: * All patients who have had any prior stem cell treatments, including HSCT * Pregnant or nursing mothers or any woman intending to become pregnant in the next three years * Use of systemic chemotherapeutic or anti-mitotic medications within three months of study start date due to the possibility of interference with bone marrow procedure * History of central nervous system infection or immunodeficiency syndromes due to increased risk of CNS infection * Patients who are anticipated to have difficultly accessing the intrathecal space related to scoliosis, obesity, or any other relevant factors determined by the PI. * Patients who have not tried available therapies for their progressive MS

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Conditions

The condition(s) this trial relates to.

chronic progressive multiple sclerosis multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple sclerosis

Contacts and locations

Locations

  • Tisch MS Research Center of New York

    New York, New York, 10019, United States

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