Nasal spray of umbilical cord mesenchymal stem-cell exosomes for children with autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a 24-week, randomized, open-label Phase 1/2 trial enrolling 40 children with ASD who meet DSM-5 or ICD-11 diagnostic criteria and have a CARS2 score of 30 or higher. Participants will be randomized 1:1 to receive an active intranasal hUC-MSC-derived exosome spray given every other day for a total of 10 administrations, or to a no-intervention control group that undergoes the same assessments and safety monitoring. The study will monitor safety outcomes and changes in core ASD symptoms over the study period. Investigators will collect clinical scales and safety labs at scheduled visits to characterize tolerability and preliminary efficacy signals.

Why it matters

Who can join: the full rules

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.

Where it's running

• Dongfang People's Hospital
  Dongfang, Hainan, China Recruiting

Study contacts

• Study coordinator: Zhongmin Liu
• Email: dfsrmyykjk@126.com
• Phone: +86-0898-38932608

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.