Autism Spectrum Disorder
Conditions
Interventions
Exosome Group:3D exosomes (derived from umbilical cord mesenchymal stem cells), intranasal administration, 5×10^9 particles per dose, once daily for 8 weeks
Placebo Group:Equal volume placebo, intranasal administration, once daily for 8 weeks
Sponsors
Beijing An Ding Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Age between 6 and 12 years (6 years = 30. 4. No psychiatric medication use within three months prior to enrollment, or stable use of psychiatric medications for three months or longer. 5. Both the participant and their legal guardian(s) agree to participate in this trial and sign the informed consent form (the legal guardian must sign the guardian version of the informed consent form; children aged 8 years or older must sign the minor version, while children under 8 years of age will receive verbal informed assent).
Exclusion criteria
Exclusion criteria: 1. The participant or legal guardian is unable to fully understand Chinese instructions. 2. Diagnosed with Rett syndrome, Childhood Disintegrative Disorder, Fragile X syndrome, or other inherited metabolic disorders that may affect cognitive development. 3. Currently presenting with psychotic symptoms or severe behavioral disorders. 4. History of suicide attempt/self-injury, or current suicidal ideation, or deemed by the investigator to be at risk of suicide. 5. Severe hematological disease, active malignancy. 6. Presence of active infection (viral, bacterial, fungal, or mycobacterial) at enrollment. 7. Current diagnosis of central nervous system disease or severe physical illness. 8. Participation in a drug clinical trial within 3 months prior to enrollment (unless the washout period has been completed), or participation in another exosome or stem cell study within 1 year prior to enrollment. 9. Presence of metal implants such as pacemakers, cochlear implants, dental braces, or conditions that preclude magnetic resonance imaging (e.g., claustrophobia). 10. Any anatomical or medical condition that, in the investigator’s clinical judgment, may interfere with intranasal administration or absorption of the study drug. 11. Any condition that, in the investigator’s opinion, makes the participant unsuitable for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Social Responsiveness Scale-2 (SRS-2); | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Autism Behavior Checklist (ABC);Change from baseline in Autism Treatment Evaluation Checklist (ATEC);Change from baseline in Repetitive Behavior Scale-Revised (RBS-R);Change from baseline in Clinical Global Impression (CGI);Change from baseline in blood inflammatory cytokines (IL-1ß, IL-4, IL-6, IL-10);Change from baseline in eye-tracking and neuroimaging parameters;Safety outcomes including incidence, severity, and relationship to investigational drug of adverse events (AE) and serious adverse events (SAE); treatment emergent adverse event (TESS) scores and individual symptom incidence; clinically significant changes from baseline in laboratory tests (complete blood count, blood biochemistry, coagulation function, urinalysis, thyroid function tests, immunoglobulins, tumor markers), vital signs, and electrocardiogram (ECG); | — |
Countries
China
Contacts
Public ContactWang Gang
Beijing An Ding Hospital, Capital Medical University
Outcome results
None listed