NCT06620809 The Safety and Efficacy of NouvSoma001 in Neuromyelitis Optica Spectrum Disorders
| NCT ID | NCT06620809 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Tongji Hospital |
| Condition | Neuromyelitis Optica Spectrum Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 69 participants |
| Start Date | 2025-03-28 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 69 participants in total. It began in 2025-03-28 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Dai-shi Tian, MD
PRINCIPAL INVESTIGATOR
Tongji Hospoital
Frequently Asked Questions
Who can join the NCT06620809 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Neuromyelitis Optica Spectrum Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06620809 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06620809 currently recruiting?
Yes, NCT06620809 is actively recruiting participants. Contact the research team at qinchuan712@126.com for enrollment information.
Where is the NCT06620809 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT06620809 clinical trial?
NCT06620809 is sponsored by Tongji Hospital. The principal investigator is Dai-shi Tian, MD at Tongji Hospoital. The trial plans to enroll 69 participants.