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.
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.
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Contacts