Prospective Clinical Study on Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes for the Treatment of Childhood Autism
NCT ID: NCT07243561
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2025-11-30
2026-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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hUC-MSC-EXOs Nasal Spray Group
hUC-MSC-Exos Nasal Spray
The total therapeutic dosage is set at 400 billion hUC-MSC-EXOs particles. Each nasal administration delivers 40 billion particles, with a total of 10 administrations completing the full course. The treatment is administered on an alternate-day schedule.
No-Intervention Control Group
No interventions assigned to this group
Interventions
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hUC-MSC-Exos Nasal Spray
The total therapeutic dosage is set at 400 billion hUC-MSC-EXOs particles. Each nasal administration delivers 40 billion particles, with a total of 10 administrations completing the full course. The treatment is administered on an alternate-day schedule.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
3 Years
7 Years
ALL
No
Sponsors
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Dongfang People's Hospital
OTHER
Responsible Party
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Locations
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Dongfang People's Hospital
Dongfang, Hainan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-DFKYLL-002
Identifier Type: -
Identifier Source: org_study_id
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