The Safety and Efficacy of NouvSoma001 in Neuromyelitis Optica Spectrum Disorders

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.