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.
Diagnosis meets the ICD-11 ASD criteria or DSM-5 ASD clinical diagnostic standards.
No significant improvement in core symptoms was observed after ≥3 months of standardized behavioral intervention.
Score ≥30 on the CARS2, indicating mild-to-moderate or more severe autism.
Aged 3 (inclusive) to 7 (inclusive) years, regardless of gender
History of severe allergic reactions.
Any severe mental disorder or other types of autism spectrum disorders.
History of epileptic seizures within the past six months.
Autism secondary to epilepsy, cerebrovascular disease, or traumatic brain injury.
Dongfang People's Hospital
Lead sponsor
Shanghai Tongjin Stem Cell Technology Co., Ltd.
Collaborator