Acute Ischemic Stroke AISPhase 1STEVIANCT06995625
The STem Cell-derived Extracellular Vesicle Therapy In Acute Ischemic Stroke (STEVIA)
A Phase 1 study testing SNE-101 in people with Acute Ischemic Stroke AIS, run by S&Ebio Co. Ltd. at 3 sites in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Ischemic Stroke AIS
- What is being tested?
- SNE-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 22 Jun 2026to 31 Mar 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea3 sites, 3 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Woo-Keun Seo, MD
Jong-Won Chung, MD
- Recruiting
Ewha Womans University Seoul Hospital
Seoul, 07804
Tae-Jin Song, MD
- Recruiting
Ajou University Hospital
Suwon, Gyeonggi-do, 16499
Jin soo Lee, MD
About this study
Official title: 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
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
Read the 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 stroke.
- Conditions
- Acute Ischemic Stroke AIS
- Being tested
- SNE-101
- Keywords
- Stroke, Exosome, Extracellular vesicles, Wharton's jelly-mesenchymal stem cell, MSC
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNE-101Drug
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 group | Role | What they receive |
|---|---|---|
| SNE-101 | Experimental | Patients 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. Receives: Drug: SNE-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of SNE-101 in patients with acute ischemic stroke and determine the Maximum Tolerated Dose (MTD)
- The Maximum Tolerated Dose (MTD) determination via the Dose limiting toxicity (DLT)
Measured: 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)
- Adverse events are monitored continuously throughout the study.
Measured: Adverse events: 180 days
Secondary outcomes (5)
To assess the efficacy of SNE-101 in patients with acute ischemic stroke.
- Mean % change in Fugl-Meyer Assessment (FMA) from baseline to Week 13
A quantitative measure used to assess motor function, balance, and joint motion in post-stroke patients. The FMA is a widely validated scale used to evaluate sensorimotor recovery, especially in the upper and lower extremities, with a maximum score of 226 indicating normal function. Higher scores indicate better motor recovery.
Measured: 13 weeks
To assess the efficacy of SNE-101 in patients with acute ischemic stroke.
- Improvement in neural tract integrity on Diffusion Tensor Imaging (DTI) from baseline to Week 13.
An advanced MRI technique used to assess the integrity and organization of white matter tracts in the brain. DTI parameters such as fractional anisotropy (FA) and mean diffusivity (MD) provide quantitative measures of axonal regeneration and neuroplasticity. Increases in FA and normalization of MD values are indicative of neural recovery after stroke.
Measured: 13 weeks
To assess the efficacy of SNE-101 in patients with acute ischemic stroke.
- Changes in NIH stroke scale (NIHSS) from baseline to Week 13
A standardized neurological examination that quantifies the severity of neurological impairment caused by stroke. The NIHSS evaluates several domains including consciousness, motor strength, language, vision, and sensory loss. Scores range from 0 to 42, with lower scores indicating milder neurological deficits.
Measured: 13 weeks
To assess the efficacy of SNE-101 in patients with acute ischemic stroke.
- Changes in modified Rankin Score (mRS) from baseline to Week 13
A global functional outcome scale that assesses the degree of disability or dependence in daily activities in patients who have suffered a stroke. Scores range from 0 (no symptoms) to 6 (death). Lower scores indicate greater functional independence and are commonly used as primary endpoints in stroke trials.
Measured: 13 weeks
To assess the efficacy of SNE-101 in patients with acute ischemic stroke.
- Changes in Infarct size from baseline to Week 13
The volume of cerebral infarction measured using MRI sequences such as diffusion-weighted imaging (DWI) and fluid-attenuated inversion recovery (FLAIR). Reduction in infarct growth or final infarct size is considered an imaging biomarker of neuroprotection. Measurements are expressed in cubic centimeters (cc) and compared over time to assess treatment efficacy.
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start22 Jun 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic Stroke AISStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- S&Ebio Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995625
- Sponsor's protocol ID
- SNE-101S
- Acronym
- STEVIA
- Status last verified
- Jul 2026
- First submitted
- 13 May 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No