[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100450606":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":24,"studyPopulation":17,"armGroups":25,"interventions":32,"overallOfficials":38,"centralContacts":17,"locations":42,"responsibleParty":75,"collaborators":17,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":17,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":17,"maxAge":17,"enrollmentInfo":85,"targetDuration":17,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":45,"whyStopped":17,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"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: Single Assessment Numeric Evaluation Score (SANE)","ranging from 0 to 100%",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 Osteoarthritis (OA). This patient funded trial aims to study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of OA. Patients with OA will receive intravenous infusion and intraarticular injection 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 (AlloRx)","EXPERIMENTAL","Intravenous infusion and intraarticular injection (total dose 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":60},{"type":76,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100450606","phase-1-safety-of-cultured-allogeneic-adult-umbilical-cord-derived-mesenchymal-stem-cells-for-oa-100450606",false,"NCT05147675","Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for OA","Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Osteoarthritis","Inclusion Criteria:\n\n* Diagnosis of Osteoarthritis\n* Understanding and willingness to sign a written informed consent document\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* Continued drug abuse\n* Pre-menopausal women not using contraception\n* Previous organ transplant\n* Hypersensitivity to sulfur","ALL",{"count":86,"type":87},92,"ESTIMATED","INTERVENTIONAL",[90],"PHASE1","This trial will study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells delivered intravenously and intraarticularly for the treatment of Osteoarthritis.",[93,94],"Osteoarthritis","Spinal Arthritis",[93,96,94],"stem cell treatment","2025-06-05",{"date":99,"type":100},"2025-06-10","ACTUAL",{"date":102,"type":100},"2022-12-01",{"date":104,"type":87},"2027-12-01",{"name":5,"class":6},2]