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

Sponsor
Shanghai Jiao Tong University School of Medicine
Study ID
NCT07433517
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
7 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • VGN-Ex05e — BIOLOGICAL
    Products derived from human embryonic stem cells for the treatment of allogeneic nerve cells

Study Details

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

Key Dates

First listed
Feb 25, 2026
Start date
Apr 30, 2026
Status verified
Feb 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
6 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: VGN-Ex05e
    Stereotactic intracerebral injection of VGN-Ex05e solution into the nucleus accumbens with 2.0×10\^6 cells or 6.0×10\^6 cells.

Primary Outcome Measure

Incidence and severity of adverse events [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

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