Prospective Clinical Study on Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes for the Treatment of Childhood Autism

Recruiting Phase 1 Phase 2 Interventional Study
Autism Spectrum Disorder (ASD Prospective Study
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
3 – 7
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Dongfang People's Hospital · Other
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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. …
Contacts

Zhongmin Liu

+86-0898-38932608

dfsrmyykjk@126.com

CONTACT