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RECRUITINGINTERVENTIONAL

Omic Profile in Autism Spectrum Disorder: From Cellular Level Towards Future Treatments

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is an interventional non pharmacological study in pediatric patientis affected by Autism Spectrum Disorder. It ams to create a collection of iPSCs and hiNSCs derived from deeply characterized ASD patients, to omics-characterize the cells, and to study the behavioral pattern of microglia-like cells in the onset of ASD.

Who May Be Eligible (Plain English)

Who May Qualify: - Defined ASD diagnosis according to DSM-5 criteria - Age 3-15 years - willing to sign a consent form signed by the guardians/legal representatives. Who Should NOT Join This Trial: - Exclusion criteria for Group 1 will be: having a defined genetic diagnosis or an overall clinical presentation strongly suggestive for a syndromic condition. For this definition we will apply the criteria ASD associated with at least one of the following: \>=3 facial anomalies, \>=1 major/\>=2 minor malformation (following EUROCAT classification), clinical issue affecting \>=2 systems. Children showing such phenotypes but having no current genetic diagnosis could not be included in the study. Patients with a syndromic presentation and confirmed genetic diagnosis will be included in the Syndromic Group 2. - No standardized test to establish diagnosis - Parents refusing to complete the consent form - Impossible blood sample collection. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Defined ASD diagnosis according to DSM-5 criteria * Age 3-15 years * Informed consent signed by the guardians/legal representatives. Exclusion Criteria: * Exclusion criteria for Group 1 will be: having a defined genetic diagnosis or an overall clinical presentation strongly suggestive for a syndromic condition. For this definition we will apply the criteria ASD associated with at least one of the following: \>=3 facial anomalies, \>=1 major/\>=2 minor malformation (following EUROCAT classification), clinical issue affecting \>=2 systems. Children showing such phenotypes but having no current genetic diagnosis could not be included in the study. Patients with a syndromic presentation and confirmed genetic diagnosis will be included in the Syndromic Group 2. * No standardized test to establish diagnosis * Parents refusing to complete the consent form * Impossible blood sample collection.

Treatments Being Tested

BIOLOGICAL

Blood sample collection for ASD cells model production and Omic studies

The blood sample collection performed in the study is for research purposes only and therefore not collected for clinical purposes. The patient cohort is extensively studied and well stratified, so cell models production and subsequent Omic analyses could be cross-referenced with detailed phenotype data.

Locations (1)

Foundation IRCCS Carlo Besta Neurological Institute
Milan, Italy