[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527112":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":24,"studyPopulation":17,"armGroups":25,"interventions":32,"overallOfficials":38,"centralContacts":42,"locations":47,"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":85,"maxAge":17,"enrollmentInfo":86,"targetDuration":17,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":97,"overallStatus":50,"whyStopped":17,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"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: Global Improvement Score (GI)","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","Stem cell treatment has shown efficacy for PCOS in both human and animal studies. Complete resolution was seen of polycystic ovary syndrome (PCOS) in a young woman after a single intravenous injection of umbilical cord derived mesenchymal stem cells (UCDSC). It is hypothesized that intravenous infusion of UCDSC can reduce or eliminate PCOS. Patients will receive roughly 2 million umbilical cord derived mesenchymal stem cells per kg of body weight. Hormone levels and ultrasound will be checked 3,6 and 12 months after treatment.",[26],{"label":27,"type":28,"description":29,"interventionNames":30},"Treatment Group (AlloRx)","EXPERIMENTAL","Intravenous infusion",[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 C Prodromos, MD","PRINCIPAL_INVESTIGATOR",[43],{"name":40,"role":44,"phone":45,"phoneExt":17,"email":46},"CONTACT","8476996810","research@ismoc.net",[48,62],{"facility":49,"status":50,"city":51,"state":17,"zip":17,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Medical Surgical Associates Center","RECRUITING","St John's","Antigua and Barbuda","AG",{"type":55,"coordinates":56},"Point",[57,58],-61.84329,17.12096,{"lat":58,"lon":57},[61],{"name":40,"role":44,"phone":17,"phoneExt":17,"email":17},{"facility":63,"status":50,"city":64,"state":17,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Athens Beverly Hills Medical Group","Glyfada","16675","Greece","GR",{"type":55,"coordinates":69},[70,71],23.75802,37.86289,{"lat":71,"lon":70},[74],{"name":40,"role":44,"phone":17,"phoneExt":17,"email":17},{"type":76,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100527112","phase-1-safety-of-cultured-allogeneic-adult-umbilical-cord-derived-mesenchymal-stem-cells-for-pcos-100527112",false,"NCT06143527","Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for PCOS","Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Polycystic Ovary Syndrome","Inclusion Criteria:\n\n• Ultrasound documented poly cystic ovary syndrome\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* Previous organ transplant\n* Hypersensitivity to sulfur\n* Inability to supply proper informed consent","FEMALE","18 Years",{"count":87,"type":88},20,"ESTIMATED","INTERVENTIONAL",[91],"PHASE1","This trial will study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells delivered intravenously for the treatment of Polycystic Ovary Syndrome.",[94,95,96],"Polycystic Ovary Syndrome (PCOS)","Polycystic Ovary Syndrome","PCOS",[94,95,96,98,99,100,101],"Stem Cell","Stem Cells","Mesenchymal Stem Cells","Umbilical Cord Derived Mesenchymal Stem Cells","2025-04-04",{"date":104,"type":105},"2025-04-08","ACTUAL",{"date":107,"type":105},"2023-11-16",{"date":109,"type":88},"2027-11-16",{"name":5,"class":6},2]