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NCT06138210: ExoCURE

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

Recruiting now Phase 1, PHASE2 Last updated 4 December 2025
What this trial tests

Phase 1, PHASE2 trial testing exosomes derived from human induced pluripotent stem cell for injection in Acute Ischemic Stroke in 29 participants. Currently enrolling.

Timeline
5 June 2024
Primary endpoint
30 March 2026
30 March 2026

Quick facts

Lead sponsorXuanwu Hospital, Beijing
PhasePhase 1, PHASE2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designsequential
Maskingquadruple
Primary purposetreatment
Enrollment29
Start date5 June 2024
Primary completion30 March 2026
Estimated completion30 March 2026
Sites1 location across China

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. 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
  5. The Landscape of Exosomes Biogenesis to Clinical Applications.
    Al-Madhagi H. · · 2024 · cited 28× · PMID 38681093 · DOI 10.2147/ijn.s463296
  6. 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
  7. 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
  8. 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:

Other recruiting trials for Acute Ischemic Stroke

Currently open trials in the same condition.

Other Xuanwu Hospital, Beijing trials

Trials by the same sponsor.

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Data sources for this page

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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