Autism
Conditions
Interventions
Experimental group:Cord Blood Mononuclear Cells
Control group:Normal saline
Sponsors
The First Medical Center of PLA General Hospital
Eligibility
Sex/Gender
All
Age
3 Years to 8 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria for ASD in The Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V); (2) Age 3-8 years old, male and female; (3) Cytokines IL-1, IL-2, IL-6, IL-8, IL-10, or any of TNF-a more than 1.5 times above the upper limit of normal by serum cytokine testing after excluding active inflammation elsewhere; (4) No known immunodeficiency diseases, and no major functional abnormalities in blood, liver, kidney, heart or lung; (5) Clinical research participants and/or guardians can fully understand the content of informed consent for this study and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with a history of combined tumors or neoplasms (including hematological tumors versus solid tumors); (2) Previous history of severe allergic reaction and blood product allergy; (3) Mental disorders other than autism and autism spectrum disorders due to active epilepsy, cerebrovascular disease, or traumatic brain injury; (4) Other conditions that, in the opinion of the investigator, make enrollment inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SRS score results;Results of ABC scores on the Vineland scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in serum inflammatory factor levels after treatment;Changes in serum metabolomics indices after treatment;Incidence of adverse events during treatment; | — |
Countries
China
Contacts
Public ContactYang Guang
The First Medical Center of PLA General Hospital
Outcome results
None listed