The Safety and Efficacy of NouvSoma001 in Neuromyelitis Optica Spectrum Disorders

Recruiting Phase 1 Interventional Study
Neuromyelitis Optica Spectrum Disorders
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At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
69 (estimated)
Sponsor
Tongji Hospital · Other
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About This Trial

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.

Trial Locations
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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 dysfunc…
Contacts

Chuan Qin, MD

86-27-83663337

qinchuan712@126.com

CONTACT

Chuan Qin, MD

86-27-83663332

chuanqin@tjh.tjmu.edu.cn

CONTACT