[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100440708":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":24,"studyPopulation":17,"armGroups":25,"interventions":32,"overallOfficials":38,"centralContacts":17,"locations":42,"responsibleParty":76,"collaborators":17,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":17,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":17,"maxAge":17,"enrollmentInfo":86,"targetDuration":17,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":45,"whyStopped":17,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"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: Gross Motor Function Measure (GMFM)","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 Cerebral Palsy (CP). This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of CP. Patients with CP will receive a single intravenous infusion of UC-MSCs. The total dose 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","Single 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],{"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","care@thepsci.com",{"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":57,"role":58,"phone":59,"phoneExt":17,"email":75},"Care@thepsci.com",{"type":77,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100440708","phase-1-safety-of-cultured-allogeneic-adult-umbilical-cord-derived-mesenchymal-stem-cell-intravenous-infusion-for-cp-100440708",false,"NCT05018819","Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for CP","Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Cerebral Palsy","Inclusion Criteria:\n\n* Diagnosis of Cerebral Palsy\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":87,"type":88},15,"ESTIMATED","INTERVENTIONAL",[91],"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 Cerebral Palsy",[94],"Cerebral Palsy",[94,96,97],"CP","stem cell treatment","2025-04-04",{"date":100,"type":101},"2025-04-08","ACTUAL",{"date":103,"type":101},"2022-02-01",{"date":105,"type":88},"2027-11",{"name":5,"class":6},2]