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NCT06138210: ExoCURE
The Effect of GD-iExo-003 in Acute Ischemic Stroke
Phase 1, PHASE2 trial testing exosomes derived from human induced pluripotent stem cell for injection in Acute Ischemic Stroke in 29 participants. Currently enrolling.
30 March 2026
Quick facts
| Lead sponsor | Xuanwu Hospital, Beijing |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 29 |
| Start date | 5 June 2024 |
| Primary completion | 30 March 2026 |
| Estimated completion | 30 March 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- exosomes derived from human induced pluripotent stem cell for injection — full drug profile →
- a placebo of exosomes derived from human induced pluripotent stem cell for injection — full drug profile →
Conditions studied
- Acute Ischemic Stroke — all drugs for Acute Ischemic Stroke →
Sponsor
Xuanwu Hospital, Beijing
Who can join
Adults 18 to 70, any sex, with Acute Ischemic Stroke. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Understanding the Pathophysiology of Ischemic Stroke: The Basis of Current Therapies and Opportunity for New Ones.
Salaudeen MA, Bello N, Danraka RN, Ammani ML. · · 2024 · cited 89× · PMID 38540725 · DOI 10.3390/biom14030305 -
Insight into the Functional Dynamics and Challenges of Exosomes in Pharmaceutical Innovation and Precision Medicine.
Sharma A, Yadav A, Nandy A, Ghatak S. · · 2024 · cited 40× · PMID 38931833 · DOI 10.3390/pharmaceutics16060709 -
Exosome-powered neuropharmaceutics: unlocking the blood-brain barrier for next-gen therapies.
Mehdizadeh S, Mamaghani M, Hassanikia S, Pilehvar Y, et al · · 2025 · cited 34× · PMID 40319325 · DOI 10.1186/s12951-025-03352-8 -
Emerging Role of Extracellular Vesicles as Biomarkers in Neurodegenerative Diseases and Their Clinical and Therapeutic Potential in Central Nervous System Pathologies.
Malaguarnera M, Cabrera-Pastor A. · · 2024 · cited 30× · PMID 39337560 · DOI 10.3390/ijms251810068 -
The Landscape of Exosomes Biogenesis to Clinical Applications.
Al-Madhagi H. · · 2024 · cited 28× · PMID 38681093 · DOI 10.2147/ijn.s463296 -
Extracellular Vesicles Maintain Blood-Brain Barrier Integrity by the Suppression of Caveolin-1/CD147/VEGFR2/MMP Pathway After Ischemic Stroke.
Li Y, Chen J, Quan X, Chen Y, et al · · 2024 · cited 25× · PMID 38371456 · DOI 10.2147/ijn.s444009 -
Advancing stroke therapy: innovative approaches with stem cell-derived extracellular vesicles.
Song J, Zhou D, Cui L, Wu C, et al · · 2024 · cited 24× · PMID 39039539 · DOI 10.1186/s12964-024-01752-1 -
Comparative analysis of regulations and studies on stem cell therapies: focusing on induced pluripotent stem cell (iPSC)-based treatments.
Song SJ, Nam Y, Rim YA, Ju JH, et al · · 2024 · cited 18× · PMID 39574212 · DOI 10.1186/s13287-024-04065-9
Verify or expand the search:
- PubMed search for NCT06138210
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Acute Ischemic Stroke
Currently open trials in the same condition.
- NCT07115940 — Medical Management With Endovascular Thrombectomy Versus Medical Management Alone in Patients Presenting Beyond 24 Hours · NA · recruiting
- NCT07404852 — Non-invasive Vagus Nerve Stimulation to Reduce Inflammation and Brain Injury Blood Biomarkers Following an Acute Ischemi · NA · recruiting
- NCT07361302 — A Study to Test if Tenecteplase Helps People to Recover From an Acute Stroke When Given More Than 4.5 Hours After the Pe · Phase 3 · recruiting
- NCT07436156 — SUMMIT RISE Study of Acute Ischemic Stroke Patients · Phase 4 · recruiting
- NCT07203625 — Tenecteplase Before Interhospital Transfer in Acute Basilar Artery Occlusion at 4.5 to 24 Hours · Phase 4 · recruiting
Other Xuanwu Hospital, Beijing trials
Trials by the same sponsor.
- NCT07095933 — The Safety and Efficacy Evaluation of Everolimus as an Adjunctive Treatment for Focal Refractory Epilepsy · EARLY_PHASE1 · recruiting
- NCT07519044 — Safety and Efficacy of Adjunctive GM1 to Mechanical Thrombectomy for Acute Anterior Circulation Large Vessel Occlusion · Phase 4 · not yet recruiting
- NCT07396077 — Pre-operative Risk Assessment Combined With Targeted Intervention in the Chinese Elderly With Spine Surgery II · NA · not yet recruiting
- NCT07457125 — The Effect of CB-Exo-A600 in Mild to Moderate Alzheimer's Disease · Phase 1, PHASE2 · not yet recruiting
- NCT07479446 — Oliceridine Versus Sufentanil for Postoperative Nausea in Cerebellopontine Angle Surgery · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06138210 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Xuanwu Hospital, Beijing
- Last refreshed: 4 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06138210.
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