NCT06612710

The Safety and Efficacy of NouvSoma001 in Ischemic Stroke

An Open-label Exploratory Clinical Trial to Assess the Safety and Efficacy of NouvSoma001 in the Treatment of Ischemic Stroke

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 69 (estimated)
• Sponsor: Wei Wang · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 preliminary efficacy of intravenous administration of human-induced neural stem cell-derived extracellular vesicles (NouvSoma001) in the treatment of ischemic stroke.

Detailed description

This is a single-center, randomized, open-label, placebo-controlled, dose-escalation trial. This study will consist of 2 parts, with Part 1 being a dose-escalation study and Part 2 being a dose-extension study based on the results of Part 1. Part 1 will follow a traditional 3+3 dose-escalation design, enrolling a total of 9 subjects. Cohort 1: receive 4×10\^9 particles/kg, Cohort 2: receive 8×10\^9 particles/kg, and Cohort 3: receive 1.6×10\^10 particles/kg. If no dose-limiting toxicities (DLT) are observed within 2 weeks after the initial administration, a new cohort will be enrolled at the next higher dose level. If DLTs are observed in 1 participant, another 2 participants will be treated at the same dose level. Dose escalation will cease if DLTs are observed in more than 33% of the participants. In Part 2, the remaining 60 participants will be randomized in a 2:1 ratio to the treatment and placebo groups, with the dose level determined by the Data Safety Monitoring Board based on the results of Part 1.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
DRUG	extracellular vesicles derived from human induced neural stem cell for intravenous injection	extracellular vesicles derived from human induced neural stem cell for intravenous injection（4×10\^9 particles/kg）
DRUG	a placebo of extracellular vesicles derived from human induced neural stem cell for intravenous injection	extracellular vesicles placebo (4×10\^9 particles/kg)

Timeline

• Start date: 2025-11-30
• Primary completion: 2026-12-30
• Completion: 2027-11-30
• First posted: 2024-09-25
• Last updated: 2026-01-21

Locations

1 site across 1 country: China