NCT07243561RecruitingPhase 1/2
Prospective Clinical Study on Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes for the Treatment of Childhood Autism
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 13 Nov 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 30 Oct 2026
- Lead sponsor
- Dongfang People's Hospital
- Diseases
- Autism
- NCT number
- NCT07243561
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 60
- From 1 Sept 2025 to the primary completion date, 30 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent treatments that may interfere with the safety and efficacy evaluation of stem cell therapy.
Other illness
- 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.
Other
- Moderate or severe extrapyramidal symptoms or tardive dyskinesia.
- Severe self-injurious behavior.
- Participation in other clinical trials within the past three months.
Who the study is looking for
- 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.
Age in the registry: 3 years to 7 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dongfang People's Hospital Coordinator of this site? Confirm its status | Dongfang | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.