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New Cell-Based therapy trial aims to tame rare nerve disease

NCT ID NCT06620809

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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)
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests a new treatment called NouvSoma001 for people with neuromyelitis optica spectrum disorders (NMOSD), a rare disease that causes inflammation in the eyes and spinal cord. The treatment uses tiny particles from stem cells, given via a spinal injection, to try to control the disease. The study will enroll 69 adults who recently had symptoms and will check for safety and any signs of benefit.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 69 people

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

Started

Mar 2025

Expected to finish

Nov 2027

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 65 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. Patients must meet the 2015 International Consensus Diagnostic Criteria for Neuromyelitis Optica Spectrum Disorder (NMOSD) and test positive for AQP4 antibodies. 2. Symptom onset occurred within 7 days prior to enrollment, with associated severe pain, lower limb motor dysfunction, or urinary/bowel impairment. 3. Males or Females aged between 18 and 65 years. 4. The Expanded Disability Status Scale (EDSS) score prior to the current disease episode is ≤ 4. 5. Female participants of childbearing potential must present a negative pregnancy test at screening and agree to use effective contraception throughout the study period. 6. Informed consent must be obtained from the patient or their legal representative, with a signed consent form must be provided. Exclusion Criteria: 1. Abnormal laboratory indicators of the subjects need to be excluded, including, but not limited to, the following indicators: White Blood Cell Count \<3\*10\^9/L Neutrophil Count \<1.5\*10\^9/L \<1.5\*10\^9/L Hemoglobin \<85 \<85 g/L Platelet Count \<80\*10\^9/L \<80\*10\^9/L Serum Creatinine \>1.5\*ULN Total Bilirubin \>1.5\*ULN AST (GOT) \>3\*ULN ALT (GPT) \>3\*ULN Alkaline Phosphatase \>2\*ULN (AST = Aspartate Aminotransferase; GOT = Glutamic-Oxaloacetic Transaminase; ALT = Alanine Aminotransferase; GPT = Glutamic-Pyruvic Transaminase) 2. Any contraindications to lumbar puncture. 3. Pregnant or breastfeeding women, and patients with plans to conceive during the trial. 4. Patients with a known history of allergies to human-derived biological products or those with an allergic predisposition. 5. Patients who have undergone hematopoietic stem cell transplantation or lymphatic irradiation before enrollment. 6. Patients who have participated in any other clinical trial within the last 3 months. 7. Patients with severe comorbidities, including immunodeficiency or coagulation disorders. 8. Patients with active suicidal ideation within 6 months before screening or have a history of suicide attempts within 3 years before screening. 9. Patients with severe psychiatric symptoms that prevent clinical cooperation. 10. Patients with positive for alcohol addiction or drug abuse. 11. Patients with malignant tumors. 12. Patients who have experienced any of the following events within 12 weeks before enrollment: myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association Class IV heart failure. 13. Patients with persistent systemic infections and severe local infections. 14. Patients unable to undergo magnetic resonance imaging during the trial. 15. Patients deemed unsuitable for participation by the investigator.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430000, China

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