The STem Cell-derived Extracellular Vesicle Therapy In Acute Ischemic Stroke (STEVIA) (NCT06995625) | Clinical Trial Compass
Not Yet RecruitingPhase 1
The STem Cell-derived Extracellular Vesicle Therapy In Acute Ischemic Stroke (STEVIA)
South Korea18 participantsStarted 2025-08-01
Plain-language 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
Who can participate
Age range19 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
To evaluate the safety and tolerability of SNE-101 in patients with acute ischemic stroke and determine the Maximum Tolerated Dose (MTD)
Timeframe: MTD: within 19 days after first dose
2
To evaluate the safety and tolerability of SNE-101 in patients with acute ischemic stroke and determine the Maximum Tolerated Dose (MTD)