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RECRUITING
NCT06620809
PHASE1

The Safety and Efficacy of NouvSoma001 in Neuromyelitis Optica Spectrum Disorders

Sponsor: Tongji Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

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)

DRUG

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