Gene therapy particles aim to boost stroke recovery
NCT ID NCT06995625
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute ischemic stroke (AIS) are added.
By submitting, you agree to our Terms of use
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.
-
The places running it
3 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGSuwon, Gyeonggi-do, 16499, South Korea
-
Ewha Womans University Seoul Hospital
RECRUITINGSeoul, 07804, South Korea
-
Samsung Medical Center
RECRUITINGSeoul, 06351, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a diabetes drug help the brain heal after a stroke?
- Stroke treatment upgrade: adding a Clot-Buster after clot removal may boost recovery
- Balloon catheters may improve stroke clot removal
- Blood test may forecast stroke severity
- Could a single shot boost stroke recovery? new trial aims to find out
- One-Stop stroke care could save minutes and lives