Ireland
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Recruiting Phase 1

The STem Cell-derived Extracellular Vesicle Therapy In Acute Ischemic Stroke (STEVIA)

NCT06995625 · tracked via the Priya Life Science South Korea tracker
Sponsor
S&Ebio Co. Ltd
Phase
Phase 1
Started
2026-06-22
Last updated
2026-07-06

Condition(s) studied

Acute Ischemic Stroke AIS

Investigational drug(s) / intervention(s)

SNE-101

SNE-101: Experimental: Cohort 1 - SNE-101 4.8 × 10e10 particles (n=3 to 6) Experimental: Cohort 2 - SNE-101 9.6 × 10e10 particles (n=3 to 6) Experimental: Cohort 3 - SNE-101 19.2 × 10e10 particles (n=3 to 6)

Study summary

This is a multicenter open-label, single-arm, dose escalation phase I clinical trial to evaluate the safety and tolerability of SNE-101 in patients with acute ischemic stroke

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adults with 19 years or older * Patients within 5 days of symptom onset who have not received thrombolytic therapy or undergone endovascular reperfusion procedures. * Patients within 5 days of symptom onset who have received thrombolytic therapy or undergone endovascular reperfusion procedures but show no clinical recovery after 2 days of observation. * Imaging findings must meet both of the following: * Infarction within the middle cerebral artery territory on diffusion-weighted imaging (DWI) * Infarct size ≥ 20 mm in the longest diameter on DWI * Neurological status meeting all three of the following NIHSS criteria: * Moderate to severe neurological deficit (NIHSS score between 5-21) * New onset of motor weakness (score 2-4 in at least one of NIHSS items 5a, 5b, 6a, or 6b) * No impaired consciousness (score 0-1 on NIHSS items 1a, 1b, and 1c) * Voluntary written informed consent Exclusion Criteria: Subjects are ineligible if they meet any of the following: * Pre-stroke disability (pre-stroke mRS ≥ 2) * Likely to recover spontaneously, based on all three of: * No longer meeting the NIHSS inclusion criteria 48 hours post-thrombolysis or endovascular therapy * Lacunar stroke due to small vessel occlusion * SAFE (Shoulder Abduction and Finger Extension) score ≥ 5 * Presence or risk of malignant middle cerebral artery infarction with brain edema * Significant medical history within the past 5 years: * Severe heart failure * Severe infectious disease * Severe hepatic failure or renal failure * Newly diagnosed or actively treated cancer * Any systemic disease deemed by investigator to significantly reduce life expectancy * Any condition likely to hinder follow-up during the study * Diagnosed severe psychiatric illness: * Moderate or greater depression pre-stroke with functional impairment and suicide risk * Pre-stroke dementia interfering with daily living (CDR ≥ 2) * Contraindication to MRI (e.g., pacemaker) * Pregnant or breastfeeding, or unwilling to use effective contraception method for 90 days after last dose. * Participation in another clinical trial within the past 3 months * Any other reason determined by the investigator that would prevent participation

Primary outcome measure(s)

  • To evaluate the safety and tolerability of SNE-101 in patients with acute ischemic stroke and determine the Maximum Tolerated Dose (MTD) — MTD: within 19 days after first dose
    o The Maximum Tolerated Dose (MTD) determination via the Dose limiting toxicity (DLT)
  • To evaluate the safety and tolerability of SNE-101 in patients with acute ischemic stroke and determine the Maximum Tolerated Dose (MTD) — Adverse events: 180 days
    o Adverse events are monitored continuously throughout the study.

Trial sites (3)

FacilityCityRegionStatus
Ajou University Hospital Suwon Gyeonggi-do Recruiting
Samsung Medical Center Seoul South Korea Recruiting
Ewha Womans University Seoul Hospital Seoul South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06995625 on ClinicalTrials.gov ↗ ← All trials in South Korea