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Could a nasal spray help stroke patients heal? new trial launches

NCT ID NCT07398612

Disease control Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests a nasal spray made from human stem cell exosomes in 60 people who recently had a stroke. The spray is given once or daily for 14 days, alongside standard care. The main goal is to see if it is safe, and researchers will also check if it helps improve brain function and reduce damage.

What this could mean

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

Active substance
Human adipose-derived stem cell exosomes (nasal spray)
What this could lead to
If it works, this could point toward a new way to help people recover from stroke without surgery or strong drugs.
What could go wrong
This is an early Phase 1/2 trial with only 60 people, so it is mainly checking safety. The treatment may not improve recovery, and side effects are unknown.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 60 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 80 years

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: 1. Age 18-80 years, male or female 2. Patients with acute ischemic stroke within 72 hours of symptom onset 3. Internal carotid artery system stroke 4. For the single-dose study: mild stroke patients (NIHSS score 1-4, inclusive of 1 and 4) 5. For the multiple-dose study: moderate stroke patients (NIHSS score 5-12, inclusive of 5 and 12) 6. Pre-stroke mRS score ≤ 1 7. Subjects or their guardians voluntarily sign the informed consent form Exclusion Criteria: 1. Moderate or severe stroke (NIHSS score \> 12). 2. Lacunar infarction, brainstem or cerebellar infarction (confirmed by DWI-MRI). 3. Requirement for endovascular interventional treatment for the current episode. 4. Intracranial hemorrhagic diseases (including parenchymal, intraventricular, subarachnoid hemorrhage, etc.). 5. Patients with malignant tumors. 6. Patients with severe traumatic brain injury. 7. Patients with primary or secondary immunodeficiency diseases or requiring immunosuppressant medication. 8. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 3 times the upper limit of normal. 9. Chronic kidney disease or current serum creatinine exceeding 1.5 times the upper limit of normal or estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m². 10. Presence of severe infection or fever; patients with severe respiratory diseases. 11. Positive for hepatitis B virus surface antigen (HBsAg); or positive for hepatitis B core antibody (HBcAb) with positive HBV-DNA; or positive for hepatitis C virus antibody (HCVAb), Treponema pallidum antibody (TPAb/RPR), or human immunodeficiency virus antibody (HIV). 12. Patients who are pregnant or lactating at screening, or wish to become pregnant during the study period. Patients allergic to the product 13. Patients allergic to the product or with severe allergic constitution. 14. Patients deemed unsuitable for participation by the investigator, or for whom participation may pose a greater risk. 15. Patients who have participated in another clinical trial within the past 3 months. 16. Patients with prior use of exosomes.

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Conditions

The condition(s) this trial relates to.

ischemic stroke

As listed by the trial registrant

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

Acute ischemic stroke

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.