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The Effect of GD-iExo-003 in Acute Ischemic Stroke

NCT06138210 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-12-04

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blinded, placebo-controlled, dose-escalation trial. The objective of this study is evaluating safety and preliminary efficacy of intravenous exosomes derived from human induced pluripotent stem cell (GD-iExo-003) in acute ischemic stroke.

Conditions

  • Acute Ischemic Stroke

Interventions

DRUG

exosomes derived from human induced pluripotent stem cell for injection

Exosomes derived from human induced pluripotent stem cell for injection (3.0ml, 1×10\^11particles/ml).

DRUG

a placebo of exosomes derived from human induced pluripotent stem cell for injection

Exosomes placebo, 3.0ml

Sponsors & Collaborators

  • Guidon Pharmaceutics Ltd.

    collaborator INDUSTRY

  • Xuanwu Hospital, Beijing

    lead OTHER

Principal Investigators

  • Junwei Hao, MD; PhD · Xuanwu Hospital, Beijing

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2024-06-05
Primary Completion
2026-03-30
Completion
2026-03-30

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 NCT06138210 on ClinicalTrials.gov