Proteomic Biomarker Tests in Blood Samples from Children with Autism Spectrum Disorder (ASD)
Recruiting now
Conditions studied: Autistic Disorder
In brief
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.
Key facts
- Study ID
- NCT02168868
- Run by
- Benjamin Gesundheit
- People needed
- 900
- Starts
- 2013-05-01
- Expected to finish
- 2030-12-01
- Last updated by the study team
- 2024-11-25
Who can join
Age: 1 and older, up to 19. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male and female children
- Child aged 2-12 years with diagnosed ASD according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV (299.00) or DSM-V (299.00) OR Child aged 2-18 years diagnosed ASD according to DSM-IV (299.00) or DSM-V (299.00) AND scheduled to undergo stem cell transplantation OR Child aged 10-19 months not diagnosed with ASD but with a sibling diagnosed with ASD according to (DSM)-IV (299.00) or DSM-V (299.00) (herein termed "high-risk infants") OR Mothers of recruited high-risk infants OR A typically developing child aged 2-12 years with no signs of ASD or history of ASD in the immediate family
- Informed consent signed by the parent/legal guardian
You may not qualify if…
- Child and/or mother completed treatment with systemic steroids or immune suppressants less than 4 weeks before the screening visit
- Child and/or mother diagnosed with severe infectious diseases or sepsis over the last 6 months
- Child with ASD treated for a severe convulsive disorder (intractable seizures)
- Child and/or mother with hematological or malignant disorder
- For children in the SCT cohort: No new planned immune-modulating treatment (other than SCT) for at least 6 months before or after planned stem cell transplantation date
- If the PI suspects that the participant will not comply with study requirements, the participant may be excluded.
Where it is running
- Shaare Zedek Medical Center — Jerusalem, Israel (enrolling)
Full record on ClinicalTrials.gov
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