NCT07433517

VGN-Ex05e in Patients With Autism Spectrum Disorder Associated With Severe Self-Injurious and Aggressive Behaviors

An Early-Phase Clinical Study to Evaluate the Tolerability, Safety, and Efficacy of VGN-Ex05e in Patients With Autism Spectrum Disorder (ASD) Associated With Severe, Treatment-Resistant Self-Injurious and Aggressive Behaviors

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 7 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and tolerability of intracerebral injection of VGN-Ex05e in the nucleus accumbens of patients with autism spectrum disorder.

Detailed description

This study is a single-center, open-label, Investigator-Initiated Trial. The entire trial is expected to enroll 6 subjects. The initial plan of this study is to explore two doses: 2.0×10\^6 cells and 6.0×10\^6 cells. During the trial, the SRC (Safety Review Committee) will conduct a comprehensive assessment and may adjust the dose as necessary.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
BIOLOGICAL	VGN-Ex05e	Products derived from human embryonic stem cells for the treatment of allogeneic nerve cells

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2026-02-25
• Last updated: 2026-02-25