Recruiting NCT06995625

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

Phase I Interventional Acute Ischemic Stroke AIS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: SNE-101.
Who it may be relevant to: Registry conditions: Acute Ischemic Stroke AIS. Basic parameters: from 19 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: South Korea
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

Drug 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)

Primary outcome measures

To evaluate the safety and tolerability of SNE-101 in patients with acute ischemic stroke and determine the Maximum Tolerated Dose (MTD) [Time frame: MTD: within 19 days after first dose]
To evaluate the safety and tolerability of SNE-101 in patients with acute ischemic stroke and determine the Maximum Tolerated Dose (MTD) [Time frame: Adverse events: 180 days]

Secondary outcome measures (5)

To assess the efficacy of SNE-101 in patients with acute ischemic stroke. [Time frame: 13 weeks]
To assess the efficacy of SNE-101 in patients with acute ischemic stroke. [Time frame: 13 weeks]
To assess the efficacy of SNE-101 in patients with acute ischemic stroke. [Time frame: 13 weeks]
To assess the efficacy of SNE-101 in patients with acute ischemic stroke. [Time frame: 13 weeks]
To assess the efficacy of SNE-101 in patients with acute ischemic stroke. [Time frame: 13 weeks]

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Treatment

Study locations

South Korea · 3 centers

Ajou University Hospital — Suwon
Samsung Medical Center — Seoul
Ewha Womans University Seoul Hospital — Seoul

Identifiers

NCT: NCT06995625 · SNE-101S

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗