Stem Cell Exosome Nasal Spray for Children With Autism
Tests a nasal spray made from stem cell exosomes in young children with autism.
Key facts
- Who runs it
- Dongfang People's Hospital
- Where
- Dongfang, ChinaSee the site
- Trial code
- Registry title
- Prospective Clinical Study on Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes for the Treatment of Childhood Autism
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 60 people, planned
- Started
- 1 Sept 2025
- Planned end
- 30 Oct 2026
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- hUC-MSC-Exos Nasal Spray
- Record updated
- 16 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children aged 3 to 7 with autism spectrum disorder whose core symptoms did not improve with behavioral therapy. It tests an exosome nasal spray.
- Age
- 3 to 7 years (both included)
- Sex
- Boys and girls can join
- Disease stage
- Autism spectrum disorder (ICD-11 or DSM-5 diagnosis) with a CARS2 score of 30 or more, meaning mild-to-moderate or more severe autism
- Earlier treatment
- At least 3 months of standardized behavioral intervention without significant improvement in core symptoms
Main reasons for not taking part
- History of severe allergic reactions
- Epileptic seizures in the past six months
- Autism caused by epilepsy, cerebrovascular disease or traumatic brain injury
- Active severe infections, including human immunodeficiency virus, syphilis and hepatitis
- Took part in another clinical trial in the past three months
The registry criteria, word for word
Show all 20 criteriaShow less
Who can take part
- 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
Who cannot take part
- Concurrent treatments that may interfere with the safety and efficacy evaluation of stem cell therapy
- 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
- 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
- Other clinical conditions deemed by investigators as unsuitable for study inclusion
- Moderate or severe extrapyramidal symptoms or tardive dyskinesia
- Severe self-injurious behavior
- Participation in other clinical trials within the past three months
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 3 and 7 years old?
Where in China
- Dongfang People's HospitalDongfang, ChinaContact: Zhongmin LiuTaking people
About the trial
What the trial wants to find out
This clinical study aims to evaluate whether a nasal spray containing exosomes derived from human umbilical cord mesenchymal stem cells (hUC-MSC-EXOs) can safely and effectively improve core symptoms in children aged 3-7 years with autism spectrum disorder (ASD). It is a 24-week, non-randomized, controlled, open-label trial. Sixty pediatric patients with ASD will be non-randomly assigned at a 1:2 ratio to two groups: a no-intervention control group and an active exosome nasal spray treatment group. The treatment group will receive the nasal spray every other day, totaling 10 administrations throughout the study. The no-intervention control group will receive no experimental treatment but will undergo the same assessments and safety checks with the treatment group. This design aims to monitor the safety and efficacy of the hUC-MSC-EXOs nasal spray.
The 2 groups in the trial
- hUC-MSC-EXOs Nasal Spray GroupTreatment being tested
Treatment: hUC-MSC-Exos Nasal Spray
- No-Intervention Control GroupNo study treatment, for comparison
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Prospective Clinical Study on Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes for the Treatment of Childhood Autism
- Plain-language title
- Stem Cell Exosome Nasal Spray for Children With AutismGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07243561, who can take part
- Record updated
- 16 October 2026