Condition: Autism Spectrum Disorder (ASD · Prospective Study · Sponsor: Dongfang People's Hospital
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, non-randomized, controlled, open-label trial. Sixty pediatric patients with ASD will be non-randomly assigned at a 1:2 ratio to two groups: a no-intervention control group and an active exosome nasal spray treatment group. The treatment group will receive the nasal spray on Mondays, Wednesdays, and Fridays, 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 with the treatment group. This design aims to monitor the safety and efficacy of the hUC-MSC-EXOs nasal spray.
This description comes directly from the study's public registry record.
Zhongmin Liu · +86-0898-38932608 · dfsrmyykjk@126.com
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| Dongfang People's Hospital | Dongfang, Hainan, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07243561