Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could a nasal spray help kids with autism? new trial begins

NCT ID NCT07243561

Disease control Sponsor: Dongfang People's Hospital Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This early-stage trial is testing whether a nasal spray made from stem cell exosomes can safely improve core symptoms in 40 children aged 3-7 with autism. Half the children get the spray every other day for 10 doses, while the other half receive no treatment. Researchers will track side effects and changes in autism severity over 24 weeks.

What this could mean

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

Active substance
human umbilical cord mesenchymal stem cell-derived exosomes (hUC-MSC-EXOs) nasal spray
What this could lead to
If it works, this could point toward a new way to ease core autism symptoms in children using a simple nasal spray.
What could go wrong
This is an early Phase 1/2 trial with only 40 children, so results may not apply broadly. The treatment is experimental and safety is still being checked.

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.

Started

Sep 2025

Expected to finish

Aug 2026

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

3 to 7 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: * Diagnosis meets the ICD-11 ASD criteria or DSM-5 ASD clinical diagnostic standards. * No significant improvement in core symptoms was observed after ≥3 months of standardized behavioral intervention. * Score ≥30 on the CARS2, indicating mild-to-moderate or more severe autism. * Aged 3 (inclusive) to 7 (inclusive) years, regardless of gender * Voluntary participation in this clinical study, with written informed consent provided by the patient's legal guardian, and willingness to undergo examinations, treatment, and cooperate with follow-up visits. * In the investigator's judgment, the patient is capable of understanding and complying with study requirements. Exclusion Criteria: * History of severe allergic reactions. * Any severe mental disorder or other types of autism spectrum disorders. * History of epileptic seizures within the past six months. * Autism secondary to epilepsy, cerebrovascular disease, or traumatic brain injury. * Disease severity rated as normal, borderline mental disorder, or mild mental disorder on the Clinical Global Impression scale. * Moderate or severe extrapyramidal symptoms or tardive dyskinesia. * Severe self-injurious behavior. * Active systemic or severe localized infections, including human immunodeficiency virus, syphilis, and hepatitis. * Autoimmune diseases. * Major organ impairment. * Severe pulmonary or hematological diseases, malignancies, or immunodeficiency. * Concurrent treatments that may interfere with the safety and efficacy evaluation of stem cell therapy. * Participation in other clinical trials within the past three months. * Other clinical conditions deemed by investigators as unsuitable for study inclusion.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Autism spectrum disorder (ASD) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

autism spectrum disorder

As listed by the trial registrant

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

Autism spectrum disorder (ASD) Prospective study

How to take part

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

  1. The places running it

    1 site. 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

  • Dongfang People's Hospital

    RECRUITING

    Dongfang, Hainan, China

More trials for these conditions

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