Tests SNE-101 safety in people with acute ischemic stroke
Tests SNE-101 for safety and tolerability in adults with acute ischemic stroke.
Plain-language title generated from the registry record
Registry title: The STem Cell-derived Extracellular Vesicle Therapy In Acute Ischemic Stroke (STEVIA)
Key facts
- Where
- Seoul and Suwon, South KoreaSee the 3 sites
- Phase
- Phase 1
Where in South Korea
- Ewha Womans University Seoul HospitalSeoul, South KoreaTaking people
- Samsung Medical CenterSeoul, South KoreaTaking people
- Ajou University HospitalSuwon, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- S&Ebio Co. Ltd.
- Trial code
- NCT06995625
- Record updated
- 6 July 2026
- Original description
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 strokeRead full original descriptionShow less
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
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: 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); Subjects are ineligible if they meet any of the following:; 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.