This clinical study aims to evaluate whether a nasal spray containing exosomes derived from human umbilical cord mesenchymal stem cells (hUC-MSC-EXOs) can safely and effectively improve core symptoms in children aged 3-7 years with autism spectrum disorder (ASD). It is a 24-week, randomized, controlled, open-label trial. Forty pediatric patients with ASD will be randomly assigned at a 1:1 ratio to two groups: an active exosome nasal spray treatment group and a no-intervention control group. The treatment group will receive the nasal spray every other day, totaling 10 administrations throughout the study. The no-intervention control group will receive no experimental treatment but will undergo the same assessments and safety checks concurrently with the treatment group. This design aims to monitor the safety and efficacy of the hUC-MSC-EXOs nasal spray.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
The total therapeutic dosage is set at 400 billion hUC-MSC-EXOs particles. Each nasal administration delivers 40 billion particles, with a total of 10 administrations completing the full course. The treatment is administered on an alternate-day schedule.
Dongfang People's Hospital
Dongfang, Hainan, China
RECRUITINGNumber of Participants with Treatment-Related Adverse Events
The incidence of treatment-related adverse events will be assessed and graded according to the Common Terminology Criteria for Adverse Events version 5.0. The number of participants experiencing any treatment-related adverse event will be recorded and reported.
Time frame: Week 2, Week 6, Week 24
Childhood Autism Rating Scale, Second Edition (CARS-2) Score
Scale Description: The CARS-2 is a 15-item behavior rating scale used to diagnose and assess the severity of ASD. Range of Scores: 15 to 60. Interpretation: A higher score indicates a worse outcome.
Time frame: Week 6, Week 24
Autism Behavior Checklist (ABC)
Scale Description: The ABC is a 57-item checklist used to screen for and assess behaviors associated with ASD. Range of Scores: 0 to 158. Interpretation: A higher score indicates a worse outcome.
Time frame: Week 6, Week 24
Serum Level of Tumor Necrosis Factor-Alpha (TNF-α)
Serum concentration of the inflammatory cytokine TNF-α. The unit of measure is pg/mL.
Time frame: Week 6, Week 24
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