Actively Recruiting
Prospective Clinical Study on Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes for the Treatment of Childhood Autism
Led by Dongfang People's Hospital · Updated on 2026-04-14
40
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
Sponsors
D
Dongfang People's Hospital
Lead Sponsor
S
Shanghai Tongjin Stem Cell Technology Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prospective Clinical Study on Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes for the Treatment of Childhood Autism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis meets ICD-11 or DSM-5 criteria for autism spectrum disorder
- No significant improvement in core symptoms after 3 or more months of standard behavioral intervention
- Childhood Autism Rating Scale (CARS2) score of 30 or higher
- Aged between 3 and 7 years, any gender
- Voluntary participation with written informed consent from legal guardian
- Capable of understanding and following study requirements as judged by the investigator
You will not qualify if you...
- History of severe allergic reactions
- Presence of severe mental disorders or other autism spectrum disorder types
- Epileptic seizures within the past 6 months
- Autism due to epilepsy, cerebrovascular disease, or traumatic brain injury
- Disease severity rated as normal, borderline, or mild on Clinical Global Impression scale
- Moderate or severe extrapyramidal symptoms or tardive dyskinesia
- Severe self-injurious behavior
- Active systemic or severe localized infections including HIV, syphilis, hepatitis
- Autoimmune diseases
- Major organ impairment
- Severe pulmonary or blood diseases, cancers, or immunodeficiency
- Concurrent treatments affecting stem cell therapy evaluation
- Participation in other clinical trials within past 3 months
- Other conditions deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Dongfang People's Hospital
Dongfang, Hainan, China
Actively Recruiting
Research Team
Z
Zhongmin Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here