Autism Spectrum Disorder
Conditions
Interventions
treatment group(high-dose group):ALT002(160ug/d) nasal spray
treatment group(low-dose group):ALT002(80ug/d) nasal spray
Sponsors
The First Medical Center of the Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
3 Years to 8 Years
Inclusion criteria
Inclusion criteria: 1. The subject and their legal guardian understand and are willing to participate in this trial, and the legal guardian signs the informed consent form; 2. Aged 3 to 8 years old (including 3 years old, based on the date of signing the informed consent form), with no gender restriction; and the subject’s age shall be < 8 years old during the treatment period; 3. Diagnosed with autism spectrum disorder (ASD) by two pediatric neurology or psychiatry professionals at the associate chief physician level or above, based on the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders,Fifth Edition(DSM-5), and meeting the ASD diagnostic criteria of the Autism Diagnostic Observation Schedule,Second Edition (ADOS-2); 4. A score of < 70 on the Wechsler Preschool and Primary Scale of Intelligence (WPPSI) or the Wechsler Intelligence Scale for Children (WISC), indicating intellectual disability; 5. Serum levels of any one of the cytokines IL-1,IL-2,IL-6,IL-8,or TNF-a exceeding 1.5 times the upper limit of normal; 6. Stable medication use for at least 4 weeks, or a washout period of at least 4 weeks; if the subject has received stable non-pharmacological educational, behavioral, and/or dietary interventions, they must have participated in these programs continuously for at least 3 months before screening; 7. The subject has stable care conditions, can be under the responsibility of the same guardian during the study period, and it is expected that environmental factors such as living and residential conditions will remain as consistent as possible during the study period.
Exclusion criteria
Exclusion criteria: 1. Malnutrition, body weight < 15 kg, or presence of severe congenital underlying diseases; 2. Known diagnosis of genetic diseases, which are deemed unsuitable for inclusion by the investigator; 3. A history of epilepsy with seizures in the past; 4. Concomitant history of severe head trauma, acquired brain injury, or diagnosis of encephalitis; 5. Subjects with a history of any unstable physical or neurological diseases or currently suffering from such diseases, who, as judged by the investigator, may be at risk of major adverse events during the trial or may interfere with the assessment of safety and efficacy; 6. Subjects currently diagnosed with psychotic disorders such as bipolar disorder, depression, or schizophrenia; or those at risk of suicide; 7. Existing educational training and/or behavioral therapy that cannot be stabilized before screening and maintained consistently throughout the entire trial period; 8. Concomitant presence of other severe and/or uncontrolled major organ diseases or unstable systemic diseases, including but not limited to uncontrolled diabetes mellitus, unstable angina pectoris, cerebrovascular accident or transient ischemic attack (within 6 months before screening), myocardial infarction (within 6 months before screening), severe congestive heart failure, uncontrolled hypertension, uncontrolled active infection, liver, kidney or other severe metabolic diseases, and severe gastrointestinal diseases; 9. Allergic diathesis, or suspected allergy to the study drug; 10. Participation in other interventional clinical trials within 4 weeks before the current trial; or previous receipt of stem cell therapy; 11. Other patients deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SRS scale;Vinland scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood test ;CARS Scale;ATEC Scale;SNAP-IV Scale; | — |
Countries
China
Contacts
Public ContactGuang Yang
The First Medical Center of PLA General Hospital
Outcome results
None listed