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

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

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.

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