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The Safety and Efficacy of NouvSoma001 in Ischemic Stroke

NCT06612710 · 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 preliminary efficacy of intravenous administration of human-induced neural stem cell-derived extracellular vesicles (NouvSoma001) in the treatment of ischemic stroke.

Conditions

Interventions

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)

Sponsors & Collaborators

  • iRegene Therapeutics Co., Ltd.

    collaborator INDUSTRY

  • Wei Wang

    lead OTHER

Principal Investigators

  • Wei Wang, MD · Tongji Hospital

  • Daishi Tian, MD · Tongji Hospital

  • Chuan Qin, MD · Tongji Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2025-11-30
Primary Completion
2026-12-30
Completion
2027-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06612710 on ClinicalTrials.gov