Acute Ischemic Stroke AIS
Conditions
Keywords
Stroke, Exosome, Extracellular vesicles, Wharton's jelly-mesenchymal stem cell, MSC
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
Detailed description
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.
Interventions
DRUGSNE-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)
Sponsors
S&Ebio Co. Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the efficacy of SNE-101 in patients with acute ischemic stroke. | 13 weeks | o Mean % change in Fugl-Meyer Assessment (FMA) from baseline to Week 13 A quantitative measure used to assess motor function, balance, and joint motion in post-stroke patients. The FMA is a widely validated scale used to evaluate sensorimotor recovery, especially in the upper and lower extremities, with a maximum score of 226 indicating normal function. Higher scores indicate better motor recovery. |
Countries
South Korea
Contacts
CONTACTOh Young Bang, MD, Ph.D
CONTACTSeungWoo Yeon, Ph.D
Outcome results
None listed