Stem cell–derived extracellular vesicle therapy for acute ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label, single-arm phase 1 trial with dose escalation to evaluate the safety and tolerability of allogeneic Wharton's jelly–mesenchymal stem cell–derived extracellular vesicles (EVs) in patients with acute ischemic stroke. Eligible participants are adults 19 years or older, within 5 days of stroke onset, with specific imaging and neurological criteria, and not all patients will receive benefit; the study will also monitor preliminary efficacy signals. The primary aim is safety and tolerability, with exploratory assessments of potential efficacy. Enrollment is conducted at Ajou University Hospital, Samsung Medical Center, and Ewha Womans University Seoul Hospital in South Korea.

Why it matters

Who can join: the full rules

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

Where it's running

• Ajou University Hospital
  Suwon, Gyeonggi-do, South Korea Recruiting
• Samsung Medical Center
  Seoul, South Korea Recruiting
• Ewha Womans University Seoul Hospital
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Oh Young Bang, MD, Ph.D
• Email: ohyoung.bang@snebio.com
• Phone: +82-2-2054-8128

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.