The Safety and Efficacy of NouvSoma001 in Neuromyelitis Optica Spectrum Disorders

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Neuromyelitis Optica Spectrum Disorders

In brief

This is a single-center, randomized, open-label, placebo-controlled, dose-escalation trial. The objective of this research is to evaluate the safety, tolerability, and efficacy of intrathecal administration of human-induced neural stem cell-derived extracellular vesicles (NouvSoma001) for the treatment of neuromyelitis optica spectrum disorders.

Key facts

Study ID

NCT06620809

Run by

Tongji Hospital

People needed

69

Starts

2025-03-28

Expected to finish

2027-11-30

Last updated by the study team

2026-01-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must meet the 2015 International Consensus Diagnostic Criteria for Neuromyelitis Optica Spectrum Disorder (NMOSD) and test positive for AQP4 antibodies.
• Symptom onset occurred within 7 days prior to enrollment, with associated severe pain, lower limb motor dysfunction, or urinary/bowel impairment.
• Males or Females aged between 18 and 65 years.
• The Expanded Disability Status Scale (EDSS) score prior to the current disease episode is ≤ 4.
• Female participants of childbearing potential must present a negative pregnancy test at screening and agree to use effective contraception throughout the study period.
• Informed consent must be obtained from the patient or their legal representative, with a signed consent form must be provided.

You may not qualify if…

• 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)
• Any contraindications to lumbar puncture.
• Pregnant or breastfeeding women, and patients with plans to conceive during the trial.
• Patients with a known history of allergies to human-derived biological products or those with an allergic predisposition.
• Patients who have undergone hematopoietic stem cell transplantation or lymphatic irradiation before enrollment.
• Patients who have participated in any other clinical trial within the last 3 months.
• Patients with severe comorbidities, including immunodeficiency or coagulation disorders.
• Patients with active suicidal ideation within 6 months before screening or have a history of suicide attempts within 3 years before screening.
• Patients with severe psychiatric symptoms that prevent clinical cooperation.
• Patients with positive for alcohol addiction or drug abuse.
• Patients with malignant tumors.
• 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.
• Patients with persistent systemic infections and severe local infections.
• Patients unable to undergo magnetic resonance imaging during the trial.
• Patients deemed unsuitable for participation by the investigator.

Where it is running

• Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)

Full record on ClinicalTrials.gov

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