[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100440706":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":24,"studyPopulation":17,"armGroups":25,"interventions":33,"overallOfficials":43,"centralContacts":17,"locations":47,"responsibleParty":83,"collaborators":17,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":17,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":17,"maxAge":17,"enrollmentInfo":93,"targetDuration":17,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":50,"whyStopped":17,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"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 intrathecal injection of cultured autologous adult adipose derived mesenchymal stem cells (AD-MSCs) versus cultured allogeneic adult umbilical-cord derived mesenchymal stem cell for the treatment of SCI. Patients with SCI will receive a single intrathecal injection of AD-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 intrathecal injection of 100 million cells",[31,32],"Biological: autologous adipose derived mesenchymal stem cells","Biological: AlloRx",[34,39],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":17},"BIOLOGICAL","autologous adipose derived mesenchymal stem cells","cultured autologous adult adipose derived mesenchymal stem cells",[27],{"type":35,"name":40,"description":41,"armGroupLabels":42,"otherNames":17},"AlloRx","Cultured Allogeneic Adult Umbilical-cord Derived Mesenchymal Stem Cell Intrathecal injection for",[27],[44],{"name":45,"affiliation":5,"role":46},"Chadwick Prodromos, MD","PRINCIPAL_INVESTIGATOR",[48,66],{"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":62,"role":63,"phone":64,"phoneExt":17,"email":65},"Chadwick C Prodromos, MD","CONTACT","847-699-6810","care@thepsci.net",{"facility":67,"status":50,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Athens Beverly Hills Medical Group","Glyfada","Athens","16675","Greece","GR",{"type":55,"coordinates":74},[75,76],23.75802,37.86289,{"lat":76,"lon":75},[79,82],{"name":62,"role":63,"phone":80,"phoneExt":17,"email":81},"8476996810","care@thepsci.com",{"name":45,"role":63,"phone":17,"phoneExt":17,"email":17},{"type":84,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100440706","phase-1-safety-of-cultured-autologous-adult-adipose-derived-mesenchymal-stem-cell-versus-cultured-allogeneic-adult-umbilical-cord-derived-mesenchymal-stem-cell-intrathecal-injection-for-sci-100440706",false,"NCT05018793","Safety of Cultured Autologous Adult Adipose Derived Mesenchymal Stem Cell Versus Cultured Allogeneic Adult Umbilical-cord Derived Mesenchymal Stem Cell Intrathecal Injection for SCI","Safety of Cultured Autologous Adult Adipose Derived Mesenchymal Stem Cell Versus Cultured Allogeneic Adult Umbilical-cord Derived Mesenchymal Stem Cell Intrathecal Injection 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* Anticoagulation medicine use\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* Hypersensitivity to sulfur\n* Continued drug abuse\n* Pre-menopausal women not using contraception","ALL",{"count":94,"type":95},15,"ESTIMATED","INTERVENTIONAL",[98],"PHASE1","This trial will study the safety and efficacy of intrathecal injection of cultured autologous adult adipose derived mesenchymal stem cells versus cultured allogeneic adult umbilical-cord derived mesenchymal stem cells for the treatment of spinal cord injury",[101],"Spinal Cord Injuries",[103,104,105],"spinal cord injury","SCI","stem cell treatment","2025-04-15",{"date":108,"type":109},"2025-04-17","ACTUAL",{"date":111,"type":109},"2024-12-01",{"date":113,"type":95},"2028-12",{"name":5,"class":6},2]