The STem Cell-derived Extracellular Vesicle Therapy In Acute Ischemic Stroke (STEVIA)

Launched by S&EBIO CO. LTD. · May 21, 2025

Keywords

ClinConnect Summary

The STEVIA trial is studying a new treatment called SNE-101 for adults who have experienced an acute ischemic stroke, which happens when blood flow to the brain is blocked. This is an early-phase clinical trial that aims to find out if this treatment is safe and tolerable for patients. To participate, individuals need to be 19 years or older and must show specific signs of a recent stroke. For example, they should have had stroke symptoms starting within the last 2 to 5 days, and imaging tests must confirm a certain size and type of brain injury.

If someone is eligible to join the trial, they will receive the treatment while being carefully monitored by medical professionals. The trial is not yet recruiting participants, so it’s important to stay informed about when it will begin. This research could help improve stroke care in the future, so if you or a loved one are considering participation, it’s a good idea to discuss it with a healthcare provider for more personalized information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults with 19 years or older
• • Onset of symptoms within 2 to 5 days
• * 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