Plain-English translation of NCT06138210 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 1/2 — A combined trial that checks safety and dosing while also starting to look at whether the treatment works.
This trial is testing a new treatment called GD-iExo-003, which consists of tiny particles (called exosomes) derived from human stem cells. Researchers believe these particles may help reduce brain damage and support recovery after an acute ischemic stroke. The study will first test different doses to find the safest amount, then compare the treatment to placebo in a larger group.
Acute ischemic stroke causes sudden brain damage, and current treatments have limitations. This medication represents a new approach — using stem cell-derived particles to potentially reduce inflammation, protect brain tissue, and help patients recover better function after a stroke.
You will receive daily injections of either the new treatment or a placebo (inactive substance) for 7 consecutive days, starting within a week of your stroke. The study has two phases: first, smaller groups will receive different doses to establish safety, then a larger group will be randomly assigned to receive either the treatment or placebo. You will need to attend follow-up visits so researchers can monitor your recovery and check for any side effects.
AI-generated summary from trial data · Aug 6, 2026 · Not medical advice
China
Phase
Safety & dosing / Early efficacy
Sponsor
Xuanwu Hospital, Beijing
Collaborators
Guidon Pharmaceutics Ltd.
Enrollment target
~29 participants
Started
June 2024
Primary completion
May 2026
Age range
18 Years – 70 Years
Last updated on clinicaltrials.gov in September 2026.