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The Safety and Efficacy of NouvSoma001 in Neuromyelitis Optica Spectrum Disorders
Sponsor: Tongji Hospital
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.
Official title: An Open-Label Exploratory Clinical Trial to Assess the Safety and Efficacy of NouvSoma001 in the Treatment of Neuromyelitis Optica Spectrum Disorders
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
69
Start Date
2025-03-28
Completion Date
2027-11-30
Last Updated
2026-01-21
Healthy Volunteers
No
Conditions
Interventions
Extracellular vesicles derived from human-induced neural stem cells for intrathecal injection
Extracellular vesicles derived from human-induced neural stem cells for intrathecal injection(5×10\^9 particles)
A placebo of extracellular vesicles derived from human-induced neural stem cells for intrathecal injection
Extracellular vesicles placebo(5×10\^9 particles)
Locations (1)
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China