The STem Cell-derived Extracellular Vesicle Therapy In Acute Ischemic Stroke (STEVIA)

NCT ID: NCT06995625

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2027-03-31

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.

Conditions

Acute Ischemic Stroke AIS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SNE-101

Patients will be given SNE-101, an extracellular vesicle derived from Wharton's jelly mesenchymal stem cells.

• Drug: SNE-101

• Three multiple doses of SNE-101 will be administered to three study cohorts , each consisting of 3 to 6 subjects.
• SNE-101 will be administered intravenously once a day for 5 days.

Group Type: EXPERIMENTAL

SNE-101

Intervention Type: DRUG

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)

Interventions

SNE-101

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)

Intervention Type: DRUG

Eligibility Criteria

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

• 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

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:

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

S&Ebio Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Samsung Medical Center

Seoul, , South Korea

Ewha Womans University Seoul Hospital

Seoul, , South Korea

Countries

South Korea

Central Contacts

Oh Young Bang, MD, Ph.D

Role: CONTACT

ohyoung.bang@snebio.com

+82-2-2054-8128

SeungWoo Yeon, Ph.D

Role: CONTACT

swyeon@snebio.com

+82-2-2054-8109

Other Identifiers

SNE-101S

Identifier Type: -

Identifier Source: org_study_id