NCT06138210

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

The Effect of Exosomes Derived From Human Induced Pluripotent Stem Cell (GD-iExo-003) in Acute Ischemic Stroke: an Exploratory Study.

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multicenter, randomized, double-blinded, placebo-controlled, dose-escalation trial. This study will consist of 2 parts, with part 1 being a dose-escalation study and part 2 being an expanded safety study based on part 1 findings. A traditional 3+3 dose escalation design will be implemented in part 1. Cohort 1: receive 2×10\^9 particles/kg; cohort 2: 4×10\^9 particles/kg and cohort 3: 8×10\^9 particles/kg. If no dose-limiting toxicities (DLTs) are observed for 2 weeks after administration of the first injection, a new cohort will be enrolled at the next planned dose level. If DLTs are observed in 1 participant in the cohort, another 3 participants will be treated in the same dose level. Dose escalation will be stopped until DLTs are observed in \>33% of the participants. In part 2, 20 subjects will be randomized in a 1:1 ratio \[exosome (n=10) or exosome placebo (n=10)\]. The dose level will be determined by Data Safety Monitoring Board based on part 1.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-06-05
• Primary completion: 2026-03-30
• Completion: 2026-03-30
• First posted: 2023-11-18
• Last updated: 2025-12-04

Locations

1 site across 1 country: China