Gene therapy particles aim to boost stroke recovery

NCT ID NCT06995625

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This early-stage trial tests a new drug called SNE-101 in people who have had an acute ischemic stroke within the past five days. The main goal is to see if SNE-101 is safe and tolerable, and to find the highest safe dose. The study also looks at whether SNE-101 can improve motor function and movement after a stroke. Only a small number of participants will be enrolled to gather initial safety data.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SNE-101 (a type of gene therapy particle)
What this could lead to
If safe and effective, SNE-101 could become a new treatment to help stroke patients recover motor function.
What could go wrong
This is a very early, small Phase 1 trial focused on safety, not proof of benefit. The treatment may not work or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 18 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ajou University Hospital

    RECRUITING

    Suwon, Gyeonggi-do, 16499, South Korea

  • Ewha Womans University Seoul Hospital

    RECRUITING

    Seoul, 07804, South Korea

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

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