Tests NouvSoma001 vesicles in neuromyelitis optica spectrum disorders
Tests cell-derived vesicles injected into the spinal fluid in adults with neuromyelitis optica.
Plain-language title generated from the registry record
Registry title: The Safety and Efficacy of NouvSoma001 in Neuromyelitis Optica Spectrum Disorders
Key facts
- Where
- Wuhan, ChinaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06620809, who can take part
Where in China
- Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and TechnologyWuhan, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tongji Hospital
- Trial code
- NCT06620809
- Record updated
- 21 September 2026
- Original description
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.Read full original descriptionShow less
An Open-Label Exploratory Clinical Trial to Assess the Safety and Efficacy of NouvSoma001 in the Treatment of Neuromyelitis Optica Spectrum Disorders
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.
Inclusion: 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.
Exclusion: Patients who have undergone hematopoietic stem cell transplantation or lymphatic irradiation before enrollment; Patients with active suicidal ideation within 6 months before screening or have a history of suicide attempts within 3 years before screening; Patients with positive for alcohol addiction or drug abuse; 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 a known history of allergies to human-derived biological products or those with an allergic predisposition; Patients with severe comorbidities, including immunodeficiency or coagulation disorders; Patients with severe psychiatric symptoms that prevent clinical cooperation; Patients with malignant tumors; Patients with persistent systemic infections and severe local infections; Abnormal laboratory indicators of the subjects need to be excluded, including, but not limited to, the following indicators:; White blood cell count < 3 × 10⁹/L Neutrophil count < 1.5 × 10⁹/L Hemoglobin < 85 g/L Platelet count < 80 × 10⁹/L Serum creatinine > 1.5 × ULN Total bilirubin > 1.5 × ULN Aspartate aminotransferase (AST) > 3 × ULN Alanine aminotransferase (ALT) > 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 who have participated in any other clinical trial within the last 3 months; Patients unable to undergo magnetic resonance imaging during the trial; Patients deemed unsuitable for participation by the investigator.