[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100222106":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":57,"centralContacts":61,"locations":69,"responsibleParty":88,"collaborators":92,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":10,"eligibilityCriteria":100,"healthyVolunteers":101,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":108,"studyType":109,"phases":10,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":72,"whyStopped":10,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Cell El Ltd","INDUSTRY",[8,14,18,24,28,32],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Group of Young Children",null,"2-12 years old age \\& sex-matched controls - typically developing (TD) children",[13],"Diagnostic Test: Blood draw",{"label":15,"type":10,"description":16,"interventionNames":17},"Young Children-Autism Spectrum Disorder","2-12 years old children diagnosed with ASD according to DSM-IV (299.00) or DSM-V (299.00)",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Young Children-Autism Spectrum Disorder+SCT","2-12 years old children diagnosed with ASD according to DSM-IV (299.00) or DSM-V (299.00) due to undergo stem cell transplantation therapy",[13,22,23],"Diagnostic Test: Stool Sample Collection","Diagnostic Test: Urine Sample Collection",{"label":25,"type":10,"description":26,"interventionNames":27},"High-risk infants","Infants aged 10-19 months not diagnosed with ASD but with a sibling diagnosed with ASD",[13,22],{"label":29,"type":10,"description":30,"interventionNames":31},"Mothers of high-risk infants","Mothers of recruited infants aged 10-19 months not diagnosed with ASD but with a sibling diagnosed with ASD",[13],{"label":33,"type":10,"description":34,"interventionNames":35},"Adolescent-Autism Spectrum Disorder+SCT","12-18 years old children diagnosed with ASD according to DSM-IV (299.00) or DSM-V (299.00) due to undergo stem cell transplantation therapy",[13,22,23],[37,45,51],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DIAGNOSTIC_TEST","Blood draw","A blood sample (5 mL) will be collected.",[33,9,25,29,15,19],[43,44],"blood sample","venepuncture",{"type":38,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"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.",[33,25,19],[50],"Stool Analysis",{"type":38,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"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.",[33,19],[56],"Urinalysis",[58],{"name":59,"affiliation":5,"role":60},"Benjamin Gesundheit, MD","PRINCIPAL_INVESTIGATOR",[62,66],{"name":63,"role":64,"phone":10,"phoneExt":10,"email":65},"Benjamin Gesundheit, M.D.","CONTACT","gesundheitmd@cell-el.com",{"name":67,"role":64,"phone":10,"phoneExt":10,"email":68},"Leah Hochbaum","leah@cell-el.com",[70],{"facility":71,"status":72,"city":73,"state":10,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Shaare Zedek Medical Center","RECRUITING","Jerusalem","91031","Israel","IL",{"type":78,"coordinates":79},"Point",[80,81],35.21633,31.76904,{"lat":81,"lon":80},[84,87],{"name":85,"role":64,"phone":10,"phoneExt":10,"email":86},"Avraham Steinberg, MD","avraham@steinberg.onmicrosoft.com",{"name":85,"role":64,"phone":10,"phoneExt":10,"email":10},{"type":89,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Benjamin Gesundheit","CEO",[93],{"name":71,"class":94},"OTHER","100222106","proteomic-biomarker-tests-in-blood-samples-from-children-with-autism-spectrum-disorder-asd-100222106",false,"NCT02168868","Proteomic Biomarker Tests in Blood Samples from Children with Autism Spectrum Disorder (ASD)","Inclusion Criteria:\n\n1. Male and female children\n2. 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\n3. Informed consent signed by the parent\u002Flegal guardian\n\nExclusion Criteria:\n\n1. Child and\u002For mother completed treatment with systemic steroids or immune suppressants less than 4 weeks before the screening visit\n2. Child and\u002For mother diagnosed with severe infectious diseases or sepsis over the last 6 months\n3. Child with ASD treated for a severe convulsive disorder (intractable seizures)\n4. Child and\u002For mother with hematological or malignant disorder\n5. 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\n6. If the PI suspects that the participant will not comply with study requirements, the participant may be excluded.",true,"ALL","10 Months","19 Years",{"count":106,"type":107},900,"ESTIMATED","1 Day","OBSERVATIONAL","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.\n\nTo 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.",[112],"Autistic Disorder",[114,115,116,117,118,119,112],"Autoimmune Diseases","Child Development Disorders","Inflammation","Risk Factors","Pervasive","Autism","2024-11-21",{"date":122,"type":123},"2024-11-25","ACTUAL",{"date":125,"type":123},"2013-05",{"date":127,"type":107},"2030-12",{"name":90,"class":6},1]