NCT02168868Recruiting
Proteomic Biomarker Tests in Blood Samples from Children with Autism Spectrum Disorder (ASD)
Source: ClinicalTrials.gov · Last updated 25 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 900 (estimated)
- First submitted
- 19 Jun 2014
- Start date
- May 2013
- Primary completion date
- Dec 2030
- Lead sponsor
- Benjamin Gesundheit
- Diseases
- Autism
- NCT number
- NCT02168868
What you commit to
- Study type: Observational
- Planned participants: 900
- From May 2013 to the primary completion date, Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Child and/or mother completed treatment with systemic steroids or immune suppressants less than 4 weeks before the screening visit
- 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
Other illness
- 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
Other
- If the PI suspects that the participant will not comply with study requirements, the participant may be excluded.
Who the study is looking for
- 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
Age in the registry: 10 months to 19 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.