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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-15
SponsorFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

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.

Eligibility criteria

Qualifiers

Defined ASD diagnosis according to DSM-5 criteria

Age 3-15 years

Informed consent signed by the guardians/legal representatives.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Blood sample collection for ASD cells model production and Omic studies

Treatment groups

100 Participants
are divided into 1 treatment group