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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
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)
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Samsung Medical Center
Seoul, South Korea
Ewha Womans University Seoul Hospital
Seoul, South Korea
To evaluate the safety and tolerability of SNE-101 in patients with acute ischemic stroke and determine the Maximum Tolerated Dose (MTD)
o The Maximum Tolerated Dose (MTD) determination via the Dose limiting toxicity (DLT)
Time frame: MTD: within 19 days after first dose
To evaluate the safety and tolerability of SNE-101 in patients with acute ischemic stroke and determine the Maximum Tolerated Dose (MTD)
o Adverse events are monitored continuously throughout the study.
Time frame: Adverse events: 180 days
To assess the efficacy of SNE-101 in patients with acute ischemic stroke.
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.
Time frame: 13 weeks
To assess the efficacy of SNE-101 in patients with acute ischemic stroke.
o Improvement in neural tract integrity on Diffusion Tensor Imaging (DTI) from baseline to Week 13. An advanced MRI technique used to assess the integrity and organization of white matter tracts in the brain. DTI parameters such as fractional anisotropy (FA) and mean diffusivity (MD) provide quantitative measures of axonal regeneration and neuroplasticity. Increases in FA and normalization of MD values are indicative of neural recovery after stroke.
Time frame: 13 weeks
To assess the efficacy of SNE-101 in patients with acute ischemic stroke.
o Changes in NIH stroke scale (NIHSS) from baseline to Week 13 A standardized neurological examination that quantifies the severity of neurological impairment caused by stroke. The NIHSS evaluates several domains including consciousness, motor strength, language, vision, and sensory loss. Scores range from 0 to 42, with lower scores indicating milder neurological deficits.
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Time frame: 13 weeks
To assess the efficacy of SNE-101 in patients with acute ischemic stroke.
o Changes in modified Rankin Score (mRS) from baseline to Week 13 A global functional outcome scale that assesses the degree of disability or dependence in daily activities in patients who have suffered a stroke. Scores range from 0 (no symptoms) to 6 (death). Lower scores indicate greater functional independence and are commonly used as primary endpoints in stroke trials.
Time frame: 13 weeks
To assess the efficacy of SNE-101 in patients with acute ischemic stroke.
o Changes in Infarct size from baseline to Week 13 The volume of cerebral infarction measured using MRI sequences such as diffusion-weighted imaging (DWI) and fluid-attenuated inversion recovery (FLAIR). Reduction in infarct growth or final infarct size is considered an imaging biomarker of neuroprotection. Measurements are expressed in cubic centimeters (cc) and compared over time to assess treatment efficacy.
Time frame: 13 weeks