Phase 2 Autism Spectrum Disorder Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• The person has been diagnosed with autism spectrum disorder (ASD) based on recognised international diagnostic standards.
• Core autism symptoms have not significantly improved after at least 3 months of standard behavioural therapy.
• The person scores 30 or higher on a recognised autism assessment tool (called the CARS2), indicating at least mild-to-moderate autism.
• The person is between 3 and 7 years old (inclusive), of any gender.
• A parent or legal guardian is willing to give written consent for participation and agrees to attend appointments and follow-up visits.
• In the opinion of the trial investigators, the person is able to understand and follow the study requirements.

Who may not be able to join:

• The person has a history of severe allergic reactions.
• The person has a severe mental health condition or a different type of autism spectrum disorder.
• The person has had epileptic seizures within the past six months.
• The autism is believed to have been caused by epilepsy, a brain blood vessel condition, or a brain injury.
• The person's condition is rated as normal, borderline, or only mildly affected on a standard clinical assessment scale used by investigators.
• The person has moderate or severe movement-related side effects of a specific type (called extrapyramidal symptoms or tardive dyskinesia) (confirm with trial site).
• The person has severe self-harming behaviour.
• The person has an active widespread or serious localised infection, including HIV, syphilis, or hepatitis.
• The person has an autoimmune disease (where the body's immune system attacks itself).
• The person has serious problems affecting a major organ (such as the heart, liver, or kidneys).
• The person has severe lung disease, severe blood disorders, cancer, or a condition that weakens the immune system.
• The person is currently receiving other treatments that investigators believe could interfere with assessing the safety or effectiveness of the stem cell therapy being studied.
• The person has taken part in another clinical trial within the past three months.
• The investigators consider there to be any other medical reason the person would not be suitable for the study.

Important: Always verify eligibility with the trial site directly before applying.