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iNSC-EV01 in Acute Ischemic Stroke
NCT07143786Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Oct 2025
- Primary completion
- Jul 2027
- Sponsor
- Xuanwu Hospital
- Modality
- Lipid-based Nanoparticles, Patient-derived iPSCs, Allogeneic iPSCs
- Drugs
- iNSC-EV01
- Conditions
- ischemic stroke
01
Overview
Phase 2, randomised, double-blind trial of iNSC-EV01 in ischemic stroke (2 arms), sponsored by Xuanwu Hospital. Primary endpoints: Dose Limiting Toxicity at 90 days and Modified Rankin Scale at 90 days. Planned start Oct 2025; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Exosome Group
Intravenous iNSC-EV01
Control Group
Intravenous Placebo
03
Endpoints
Primary
Dose Limiting Toxicity
Modified Rankin Scale
Secondary
Adverse Events and Serious Adverse Events
Modified Rankin Scale
Percentage of mRS 0-2
National Institutes of Health Stroke Scale
Barthel Index
EuroQol 5-Dimension 5-Level
Infarct Volume
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