Clinical trial NCT06995625: The STem Cell-derived Extracellular Vesicle Therapy In Acute Ischemic Stroke (STEVIA)
Official title: An 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Acute Ischemic Stroke AIS
Keywords: Stroke
Exosome
Extracellular vesicles
Wharton's jelly-mesenchymal stem cell
MSC
Lead sponsor: S&Ebio Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-29
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Adults with 19 years or older
* Onset of symptoms within 2 to 5 days
* 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 outcomes:
measure: 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
measure: To evaluate the safety and tolerability of SNE-101 in patients with acute ischemic stroke and determine the Maximum Tolerated Dose (MTD)
timeFrame: Adverse events: 180 days
Secondary outcomes:
measure: To assess the efficacy of SNE-101 in patients with acute ischemic stroke.
timeFrame: 13 weeks
measure: To assess the efficacy of SNE-101 in patients with acute ischemic stroke.
timeFrame: 13 weeks
measure: To assess the efficacy of SNE-101 in patients with acute ischemic stroke.
timeFrame: 13 weeks
measure: To assess the efficacy of SNE-101 in patients with acute ischemic stroke.
timeFrame: 13 weeks
measure: To assess the efficacy of SNE-101 in patients with acute ischemic stroke.
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Seoul Hospital
Study officials:
References: