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Proteomic Biomarker Tests in Blood Samples from Children with Autism Spectrum Disorder (ASD)

NCT02168868 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 900

Last updated 2024-11-25

No results posted yet for this study

Summary

Behavioral testing is the gold standard for diagnosing autism spectrum disorder (ASD). These tests, including ADOS and ADI-R, are subjective, require trained staff to administer, are time-consuming, and can only be administered at a later age. Blood-, urine- or stool-based diagnostic biomarker test for ASD would enable objective early diagnosis, potentially even before clinical symptoms are present, eliminate the need for trained staff and enable early intervention. Such a test would not only conserve money and time but would also provide clues to ASD pathogenesis.

To date, no definitive treatment exists for ASD. Most therapies are symptom-focused, generally focusing on behavioral, social and communication skills. Recent works have reported on promising outcomes of mesenchymal stem cell (MSC) treatment of children with ASD. MSCs are multipotent, non-hematopoietic, easily isolatable and expandable stem cells involved in tissue repair, immunomodulatory responses and neuromodulation. MSC treatment of children with ASD has reportedly led to improvements in speech, sociability, eye coordination, balance, cognition and overall well-being. At the base of this approach lies the known plasticity of the human brain and immune system in the early childhood years and the ability of MSCs to modulate atypical inflammatory and immune activities. Assessment of ASD biomarker profiles in children with ASD who have undergone one or more SCT sessions may shed light on the mechanism of action, assist in better defining ASD-specific diagnostic markers and monitor treatment outcomes.

Conditions

  • Autistic Disorder

Interventions

DIAGNOSTIC_TEST

Blood draw

A blood sample (5 mL) will be collected.

DIAGNOSTIC_TEST

Stool Sample Collection

Subjects will be provided a dry, plastic, screw-top specimen container and will be asked to collect a stool sample at home.

DIAGNOSTIC_TEST

Urine Sample Collection

Subjects will be provided a dry, plastic, screw-top specimen container and will be asked to collect a urine sample at home.

Sponsors & Collaborators

  • Shaare Zedek Medical Center

    collaborator OTHER

  • Benjamin Gesundheit

    lead INDUSTRY

Principal Investigators

  • Benjamin Gesundheit, MD · Cell El Ltd

Eligibility

Min Age
10 Months
Max Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2030-12-31
Completion
2030-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02168868 on ClinicalTrials.gov