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The Safety and Efficacy of NouvSoma001 in Neuromyelitis Optica Spectrum Disorders

StatusRecruiting
PhasePhase 1
Started2025-03-28
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Nov 30, 2026 → Nov 30, 2027
See other at-risk trials from Tongji Hospital

Amendment history

2026-09-22
Primary completion pushed: 2026-11-30 → 2027-11-30
2026-01-18
Study Status, Oversight v3
Primary completion date2025-11-30→2026-11-30
2025-06-03
Study Status, Contacts/Locations v2
Study sitescontacts updated at 1 of 1 site
2025-03-28
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-11-30→confirmed 2025-03-28
Study sitesdetails revised at 1 of 1 site
2024-09-27
Original filing
Tongji Hospital
197 trials monitored
See 2 trials at risk
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 Details
NCT Number NCT06620809
Lead Sponsor Tongji Hospital
Collaborators: iRegene Therapeutics Co., Ltd.
Conditions Neuromyelitis Optica Spectrum Disorders
Enrollment 69 participants
Start Date 2025-03-28
Primary Completion 2027-11-30 (estimated)
Study Completion 2027-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-21