[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100450960":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":24,"studyPopulation":17,"armGroups":25,"interventions":32,"overallOfficials":38,"centralContacts":17,"locations":42,"responsibleParty":77,"collaborators":17,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":17,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":17,"maxAge":17,"enrollmentInfo":87,"targetDuration":17,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":45,"whyStopped":17,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"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: American Spinal Injury Association Impairment Scale (ASIA)","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 Spinal Cord Injury (SCI). This patient funded trial aims to study the safety and efficacy of intravenous and intrathecal delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of SCI. 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 intrathecal injection (total 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",[43,62],{"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":60,"email":61},"Chadwick Prodromos, M.D.","CONTACT","8476996810","200","Care@thepsci.com",{"facility":63,"status":45,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Athens Beverly Hills Medical Group","Glyfada","Athens","16675","Greece","GR",{"type":50,"coordinates":70},[71,72],23.75802,37.86289,{"lat":72,"lon":71},[75],{"name":57,"role":58,"phone":59,"phoneExt":17,"email":76},"care@thepsci.com",{"type":78,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100450960","phase-1-safety-of-cultured-allogeneic-adult-umbilical-cord-derived-mesenchymal-stem-cells-for-sci-100450960",false,"NCT05152290","Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for SCI","Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Spinal Cord Injury","Inclusion Criteria:\n\n* Diagnosis of Spinal Cord Injury\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\n* Anticoagulation medicine use","ALL",{"count":88,"type":89},20,"ESTIMATED","INTERVENTIONAL",[92],"PHASE1","This trial will study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Spinal Cord Injury.",[95],"Spinal Cord Injuries",[97,98,99],"spinal cord injury","SCI","stem cell treatment","2025-04-04",{"date":102,"type":103},"2025-04-08","ACTUAL",{"date":105,"type":103},"2022-07-06",{"date":107,"type":89},"2026-01",{"name":5,"class":6},2]