Status:
NOT_YET_RECRUITING
The STem Cell-derived Extracellular Vesicle Therapy In Acute Ischemic Stroke (STEVIA)
Lead Sponsor:
S&Ebio Co. Ltd.
Conditions:
Acute Ischemic Stroke AIS
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief 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
Detailed Description
The study aims to assess the safety, tolerability, and preliminary efficacy of allogeneic Wharton's jelly-mesenchymal stem cell-derived extracellular vesicles (EVs) in patients with acute ischemic str...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06995625
Start Date
August 1 2025
End Date
March 31 2027
Last Update
August 1 2025
Active Locations (3)
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1
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea, 16499
2
Samsung Medical Center
Seoul, South Korea, 06351
3
Ewha Womans University Seoul Hospital
Seoul, South Korea, 07804