NCT06995625 The STem Cell-derived Extracellular Vesicle Therapy In Acute Ischemic Stroke (STEVIA)
| NCT ID | NCT06995625 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | S&Ebio Co. Ltd. |
| Condition | Acute Ischemic Stroke AIS |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2026-06-22 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 18 participants in total. It began in 2026-06-22 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06995625 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Acute Ischemic Stroke AIS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06995625 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06995625 currently recruiting?
Yes, NCT06995625 is actively recruiting participants. Contact the research team at ohyoung.bang@snebio.com for enrollment information.
Where is the NCT06995625 trial being conducted?
This trial is being conducted at Suwon, South Korea, Seoul, South Korea, Seoul, South Korea.
Who is sponsoring the NCT06995625 clinical trial?
NCT06995625 is sponsored by S&Ebio Co. Ltd.. The trial plans to enroll 18 participants.
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