This clinical trial aims to evaluate the safety and preliminary efficacy of intravenous administration of human bone marrow-derived mesenchymal stem cells (hBMMSCs) in patients with autism spectrum disorder (ASD).
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized primarily by impaired social communication, restricted interests, and repetitive, stereotyped behaviors. Currently, there are no effective therapeutic drugs, and main interventions consist of educational rehabilitation and behavioral management.The purpose of this study is to evaluate the safety and preliminary efficacy of hBMMSC intravenous treatment in patients with ASD. The clinical trial intends to involve 42 participants. The trial is expected to last approximately 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Group 1: 0.5×10\^6 cells/kg (participant's body weight) single dose; Group 2: 1.0×10\^6 cells/kg (participant's body weight) single dose; Group 3: 2.0×10\^6 cells/kg (participant's body weight) single dose.
Safety Evaluation of hBMMSC Injection in ASD Patients
Adverse events and serious adverse events.
Time frame: 48 weeks
Preliminary Efficacy Evaluation of hBMMSC Injection for Patients with ASD
Changes in the scores of the Adaptive Behavior Assessment System (ABAS), Autism Behavior Checklist (ABC), Clinical Global Impression (CGI), Autism Treatment Evaluation Checklist (ATEC), Social Responsiveness Scale(SRS), Repetitive Behavior Scale-Revised (RBS-R), as well as the levels of blood inflammatory factors.
Time frame: 48 weeks
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