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

ConditionAutism Spectrum Disorder

Trial statusNot yet recruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age7-18

SponsorShanghai Jiao Tong University School of Medicine

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or Female, age >7, ≤18

DSM-5 diagnosis of Autism Spectrum Disorder, confirmed by ADOS-2

Diagnosis ≥ 2 years, with at least 6 months of unsuccessful systematic behavioral interventions or training, or those unable to undergo training;

Target symptoms and severity: Presence of recurrent self-injurious or aggressive behaviors within the last 3 months, with at least one of the following documented (meeting at least one criterion): Any self-injury item on the RBS-R scoring ≥ 3; Self-injury/aggression subscale of the BPI reaching one of the following criteria: frequency score ≥ 3, or severity score ≥ 3;

Disqualifiers

Refractory epilepsy within the last 12 months prior to screening (≥2 seizures per month or status epilepticus), or significant EEG discharges during the screening period with a high-risk assessment;

Co-occurring schizophrenia, bipolar disorder, or severe depressive disorder;

Severe cardiac, hepatic, renal, or hematologic diseases;

Coagulation disorders or bleeding tendencies (affecting surgical drug administration);

Trial design

Design model

Sequential

Treatments tested in this trial

VGN-Ex05e
Biological/Vaccine
Products derived from human embryonic stem cells for the treatment of allogeneic nerve cells

Treatment groups

6 Participants

are divided into 1 treatment group

Group A: VGN-Ex05eExperimental treatment 1 intervention