The STem Cell-derived Extracellular Vesicle Therapy In Acute Ischemic Stroke (STEVIA)
ConditionAcute Ischemic Stroke AIS
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19+
SponsorS&Ebio Co. Ltd.
About this trial
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 criteria
Qualifiers
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.
Infarction within the middle cerebral artery territory on diffusion-weighted imaging (DWI)
Disqualifiers
Pre-stroke disability (pre-stroke mRS ≥ 2)
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
Trial design
Treatments tested in this trial
- SNE-101
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov