[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100439566":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":24,"studyPopulation":17,"armGroups":25,"interventions":32,"overallOfficials":38,"centralContacts":17,"locations":42,"responsibleParty":82,"collaborators":17,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":17,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":17,"maxAge":17,"enrollmentInfo":92,"targetDuration":17,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":45,"whyStopped":17,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"The Foundation for Orthopaedics and Regenerative Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Safety (adverse events)","Clinical monitoring of possible adverse events or complications","Four year follow-up",[14],{"measure":15,"description":16,"timeFrame":12},"Efficacy: Autism Treatment Evaluation Checklist (ATEC)","ATEC is a questionnaire to measure changes in severity in response to treatment. It will be completed for each follow up point.",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"NA","SINGLE_GROUP","TREATMENT",{"masking":23,"maskingDescription":17,"whoMasked":17},"NONE","Studies have shown that stem cell treatment is safe and efficacious for the treatment of Autism. Patients with Autism will receive a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. The total dose for the infusion will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.",[26],{"label":27,"type":28,"description":29,"interventionNames":30},"Treatment Group","EXPERIMENTAL","One intravenous infusion of 100 million cells",[31],"Biological: AlloRx",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":17},"BIOLOGICAL","AlloRx","cultured allogeneic adult umbilical cord derived mesenchymal stem cells",[27],[39],{"name":40,"affiliation":5,"role":41},"Chadwick Prodromos, MD","PRINCIPAL_INVESTIGATOR",[43,61,75],{"facility":44,"status":45,"city":46,"state":17,"zip":17,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Medical Surgical Associates Center","RECRUITING","St John's","Antigua and Barbuda","AG",{"type":50,"coordinates":51},"Point",[52,53],-61.84329,17.12096,{"lat":53,"lon":52},[56],{"name":57,"role":58,"phone":59,"phoneExt":17,"email":60},"Chadwick Prodromos, M.D.","CONTACT","8476996810","research@ismoc.net",{"facility":62,"status":45,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Athens Beverly Hills Medical Group","Glyfada","Athens","16675","Greece","GR",{"type":50,"coordinates":69},[70,71],23.75802,37.86289,{"lat":71,"lon":70},[74],{"name":40,"role":58,"phone":59,"phoneExt":17,"email":60},{"facility":76,"status":45,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":77,"geoPoint":79,"contacts":80},"Mediterraneo Hospital Ilias 8-12",{"type":50,"coordinates":78},[70,71],{"lat":71,"lon":70},[81],{"name":40,"role":58,"phone":59,"phoneExt":17,"email":60},{"type":83,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100439566","phase-1-safety-of-cultured-allogeneic-adult-umbilical-cord-derived-mesenchymal-stem-cell-intravenous-infusion-for-autism-100439566",false,"NCT05003960","Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Autism","Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Autism","Inclusion Criteria:\n\n* Diagnosis of Autism\n\nExclusion Criteria:\n\n* Active infection\n* Active cancer\n* Chronic multisystem organ failure\n* Pregnancy\n* Clinically significant Abnormalities on pre-treatment laboratory evaluation\n* Medical condition that would (based on the opinion of the investigator) compromise patient's safety\n* Previous organ transplant\n* Seizure disorder\n* Hypersensitivity to sulfur","ALL",{"count":93,"type":94},15,"ESTIMATED","INTERVENTIONAL",[97],"PHASE1","This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Autism",[100],"Autism",[100,102],"stem cell treatment","2025-04-04",{"date":105,"type":106},"2025-04-08","ACTUAL",{"date":108,"type":106},"2022-01-23",{"date":110,"type":94},"2027-12-01",{"name":5,"class":6},3]