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Rebooting the immune system: can a stem cell transplant stop aggressive MS?

NCT ID NCT06228781

Cure Sponsor: Tianjin Medical University General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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)
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This status has not been confirmed recently, so it may be out of date.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 Oct 16, 2026 · Last updated Oct 16, 2026

Summary

Researchers are testing a personalized stem cell transplant for people with multiple sclerosis that has not responded to standard treatments. The procedure collects a patient's own blood-forming stem cells, uses strong chemotherapy to reset the immune system, and then returns the cells to rebuild it. The goal is to achieve long-term remission without needing ongoing MS drugs. The trial enrolls 20 adults with active, disabling MS and tracks whether they stay free of relapses and new brain lesions for three years.

What this could mean

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

Active substance
autologous hematopoietic stem cell transplantation
What this could lead to
If it works, this approach could give people with hard-to-treat multiple sclerosis years of symptom-free life without needing daily medication.
What could go wrong
The chemotherapy used to wipe out the immune system is intense and carries serious risks, including infection and organ damage. The trial is small, and some patients may still see their MS return years later.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Jan 2029

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: 1. Age 18-60 years; 2. Diagnosed multiple sclerosis with relapses or progression and sustained accumulated impairment by a neurologist expert in the field; 3. EDSS score of 3-6 (including 3 and 6); 4. EDSS cerebellar functional score ≥ 3 or EDSS pyramidal functional score ≥3； 5. Evidence of current disease activity; 6. If a patient has previously received a cytotoxic agent (mitoxantrone, cyclophosphamide etc.) they must have normal bone marrow morphology and cytogenetics before being considered eligible for this study ; 7. No evidence of hepatic inflammation or fibrosis; Exclusion Criteria: 1. Patients with evidence of myelodysplasia or other non-autoimmune cytopenia; 2. Patients having received a cytotoxic agent within one month of enrolling in this study; 3. Patient with any active or chronic infection (herpes simplex virus, varicella-zoster virus, cytomegalovirus, EB virus, human immunodeficiency virus, hepatitis virus, syphilis, etc.); 4. Patients having received a cytotoxic agent within one month of enrolling in this study; 5. Patients with a malignant tumor currently or within the last 5 years; 6. Patients with cardiac, renal, pulmonary, hepatic or other organ impairment; 7. Patients whose life expectancy is severely limited by another conditions; 8. Pregnancy or risk of pregnancy; 9. Patients unable to give written informed consent in accordance with research ethics board guidelines.

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Conditions

The condition(s) this trial relates to.

multiple sclerosis

As listed by the trial registrant

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

Multiple sclerosis

How to take part

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  1. The official record

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