The STem Cell-derived Extracellular Vesicle Therapy In Acute Ischemic Stroke (STEVIA)
STEVIA
An 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
1 other identifier
interventional
18
1 country
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2025
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2025
CompletedFirst Posted
Study publicly available on registry
May 29, 2025
CompletedStudy Start
First participant enrolled
August 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
ExpectedAugust 1, 2025
July 1, 2025
8 months
May 13, 2025
July 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To evaluate the safety and tolerability of SNE-101 in patients with acute ischemic stroke and determine the Maximum Tolerated Dose (MTD)
o The Maximum Tolerated Dose (MTD) determination via the Dose limiting toxicity (DLT)
MTD: within 19 days after first dose
To evaluate the safety and tolerability of SNE-101 in patients with acute ischemic stroke and determine the Maximum Tolerated Dose (MTD)
o Adverse events are monitored continuously throughout the study.
Adverse events: 180 days
Secondary Outcomes (5)
To assess the efficacy of SNE-101 in patients with acute ischemic stroke.
13 weeks
To assess the efficacy of SNE-101 in patients with acute ischemic stroke.
13 weeks
To assess the efficacy of SNE-101 in patients with acute ischemic stroke.
13 weeks
To assess the efficacy of SNE-101 in patients with acute ischemic stroke.
13 weeks
To assess the efficacy of SNE-101 in patients with acute ischemic stroke.
13 weeks
Study Arms (1)
SNE-101
EXPERIMENTALPatients will be given SNE-101, an extracellular vesicle derived from Wharton's jelly mesenchymal stem cells. • Drug: SNE-101 * Three multiple doses of SNE-101 will be administered to three study cohorts , each consisting of 3 to 6 subjects. * SNE-101 will be administered intravenously once a day for 5 days.
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- S&Ebio Co. Ltd.lead
Study Sites (3)
Ajou University Hospital
Suwon, Gyeonggi-do, 16499, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Ewha Womans University Seoul Hospital
Seoul, 07804, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2025
First Posted
May 29, 2025
Study Start
August 1, 2025
Primary Completion
March 31, 2026
Study Completion (Estimated)
March 31, 2027
Last Updated
August 1, 2025
Record last verified: 2025-07