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New treatment option for Acute Ischemic Stroke AIS
Official title The STem Cell-derived Extracellular Vesicle Therapy In Acute Ischemic Stroke (STEVIA)
ClinicalTrials.gov ID: NCT06995625
What this study is testing
What is SNE-101?
SNE-101 is an investigational medicine, being studied as a potential treatment for acute ischemic stroke ais.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join 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...
- Imaging findings must meet both of the following:
- Infarction within the middle cerebral artery territory on diffusion-weighted imaging (DWI)
You likely can't join if
- people 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
See the full eligibility 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
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Suwon, Gyeonggi-do, South Korea
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suwon, Gyeonggi-do, South Korea; Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.