Recruiting
Phase 1
The STem Cell-derived Extracellular Vesicle Therapy In Acute Ischemic Stroke (STEVIA)
Condition(s) studied
Acute Ischemic Stroke AIS
Investigational drug(s) / intervention(s)
SNE-101
SNE-101: Experimental: Cohort 1 - SNE-101 4.8 × 10e10 particles (n=3 to 6) Experimental: Cohort 2 - SNE-101 9.6 × 10e10 particles (n=3 to 6) Experimental: Cohort 3 - SNE-101 19.2 × 10e10 particles (n=3 to 6)
Study 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
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
Primary outcome measure(s)
- To evaluate the safety and tolerability of SNE-101 in patients with acute ischemic stroke and determine the Maximum Tolerated Dose (MTD) — MTD: within 19 days after first dose
o The Maximum Tolerated Dose (MTD) determination via the Dose limiting toxicity (DLT)
- To evaluate the safety and tolerability of SNE-101 in patients with acute ischemic stroke and determine the Maximum Tolerated Dose (MTD) — Adverse events: 180 days
o Adverse events are monitored continuously throughout the study.
Trial sites (3)
| Facility | City | Region | Status |
| Ajou University Hospital |
Suwon |
Gyeonggi-do |
Recruiting |
| Samsung Medical Center |
Seoul |
South Korea |
Recruiting |
| Ewha Womans University Seoul Hospital |
Seoul |
South Korea |
Recruiting |