Diagnosed with autism spectrum disorder in a professional Grade A Class 3 tertiary hospital Autism spectrum disorder, Neurodevelopmental disorders, Mesenchymal stem cells
Conditions
Interventions
Intravenous injection, dose of 1 times 10 to the power of 6 MSCs per kilogram per injection, once weekly for 4 consecutive weeks, plus conventional rehabilitation intervention including standard behav
Experimental Other,Active Comparator Other
UC-MSCs infusion combined with conventional rehabilitation treatment,Conventional rehabilitation treatment
Sponsors
Zibo 148 Hospital
Eligibility
Sex/Gender
All
Age
2 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Meets the clinical diagnostic criteria for Autism Spectrum Disorder (ASD), confirmed through evaluation by a child psychiatrist (based on DSM-5 or DSM-IV ASD diagnostic criteria). 2. Age: 2-12 years. 3. IQ >= 70 (high-functioning ASD), to exclude the confounding effects of intellectual disability. 4. Treatment history: Has received approximately 6 months of specialized training and neurorehabilitation therapy, but the outcomes have not met expectations (CARS score and developmental level inconsistent with chronological age). 5. Informed consent: A written informed consent form has been signed by the family/guardian, acknowledging awareness of potential treatment complications. 6. Laboratory and imaging findings: No significant abnormalities (i.e., no anemia, hepatic or renal dysfunction, positive infection markers, etc.).
Exclusion criteria
Exclusion criteria: 1.Presence of a chronic disease history (e.g., cardiovascular, hepatic, renal, or hematological disorders). 2.Presence of an infectious disease (e.g., hepatitis B/C, HIV, or other communicable diseases). 3.Presence of intracranial structural lesions such as masses, plaques, or hydrocephalus. 4.Allergy to stem cells or injection-related materials. 5.Inability to cooperate with treatment and follow-up assessments. 6.Other neurodevelopmental / psychiatric disorders: Fragile X syndrome, Rett syndrome, ADHD, intellectual disability, schizophrenia, obsessive-compulsive disorder. 7.Organic disorders: Brain injury, metabolic diseases, hearing/visual impairment (that may cause abnormalities in social communication), or epilepsy (without clear core ASD symptoms). 8.Secondary causes of symptoms: Manifestations similar to ASD resulting from factors such as medication side effects, environmental deprivation, or post-traumatic stress disorder. 9.Inability to cooperate with assessments: e.g., individuals with severe ASD who are nonverbal and lack augmentative communication tools, or individuals with severe intellectual disability. 10.Severe comorbidities: Severe epilepsy, cerebral palsy, end-stage diseases, or severe psychiatric conditions (e.g., major depressive disorder). 11.Other: Does not meet the age range requirements, previous participation in a similar interventional study, or refusal to participate by the parent/guardian or the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Behavioral Assessment Baseline , 1 month, 3 month , 6 month Autism Behavior Checklist, Childhood Autism Rating Scale, Social Responsiveness Scale, Second Edition, Denver Developmental Screening Test II, Activities of Daily Living Scale, ,Neurocognitive Assessment Baseline , 1 month, 3 month , 6 month Wechsler Intelligence Scale for Children, Fourth Edition,Neuroimaging Measures Baseline , 1 month, 3 month , 6 month sMRI, fMRI,Oxidative Stress Biomarkers Baseline , 1 month, 3 month , 6 month Glutathione, Peroxidase,Inflammatory and Immune Markers Baseline , 1 month, 3 month , 6 month Interleukin-6, Tumor Necrosis Factor-alpha, Interleukin-8,Neurotransmitters and Hormones Baseline , 1 month, 3 month , 6 month Oxytocin, Vasopressin, Serotonin,Safety assessment 1 week, 2 week, 3 week, 4 week, 1 month, 6 month Common Terminology Criteria for Adverse Events | — |
Secondary
| Measure | Time frame |
|---|---|
| Behavioral Assessment Baseline , 1 month, 3 month , 6 month Sensory Integration and Praxis Tests / Sensory Integration Scale | — |
Countries
China
Contacts
Public ContactYunliang Wang
Zibo 148 Hospital
Outcome results
None listed