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The Safety and Efficacy of NouvSoma001 in Neuromyelitis Optica Spectrum Disorders

NCT06620809 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2026-01-21

No results posted yet for this study

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.

Conditions

  • Neuromyelitis Optica Spectrum Disorders

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）

Sponsors & Collaborators

  • iRegene Therapeutics Co., Ltd.

    collaborator INDUSTRY

  • Tongji Hospital

    lead OTHER

Principal Investigators

  • Dai-shi Tian, MD · Tongji Hospoital

  • Wei Wang, MD · Tongji Hospoital

  • Chuan Qin, MD · Tongji Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-28
Primary Completion
2026-11-30
Completion
2027-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06620809 on ClinicalTrials.gov