Clinical Trial

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

Study acronym: EXO-ASD
Recruiting Phase 1/2
View on ClinicalTrials.gov →
Record status
This record was last updated July 16, 2026 (before its estimated July 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 change
notable Enrollment increased: 40 -> 60 participants 2026-07-17
Trial Details
NCT Number NCT07243561
Lead Sponsor Dongfang People's Hospital
Collaborators: Shanghai Tongjin Stem Cell Technology Co., Ltd.
Conditions Autism Spectrum Disorder (ASD, Prospective Study
Enrollment 60 participants
Start Date 2025-09-01
Primary Completion 2026-07-30 (estimated)
Study Completion 2026-07-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-16