[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100451409":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":28,"overallOfficials":34,"centralContacts":13,"locations":38,"responsibleParty":56,"collaborators":13,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":13,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":13,"maxAge":13,"enrollmentInfo":66,"targetDuration":13,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":77,"whyStopped":13,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"The Foundation for Orthopaedics and Regenerative Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Safety (adverse events)","Clinical monitoring of possible adverse events or complications","Four year follow-up",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NA","SINGLE_GROUP","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","This patient funded trial aims to study the safety and efficacy of intravenous infusion and intralesional injection of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of Skin Ulcer. 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.",[22],{"label":23,"type":24,"description":25,"interventionNames":26},"Treatment Group (AlloRx)","EXPERIMENTAL","intravenous infusion and intralesional injection of 100 million cells",[27],"Biological: AlloRx",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":13},"BIOLOGICAL","AlloRx","cultured allogeneic adult umbilical cord derived mesenchymal stem cells",[23],[35],{"name":36,"affiliation":5,"role":37},"Chadwick Prodromos, MD","PRINCIPAL_INVESTIGATOR",[39],{"facility":40,"status":13,"city":41,"state":13,"zip":13,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Medical Surgical Associates Center","St John's","Antigua and Barbuda","AG",{"type":45,"coordinates":46},"Point",[47,48],-61.84329,17.12096,{"lat":48,"lon":47},[51],{"name":52,"role":53,"phone":54,"phoneExt":13,"email":55},"Chadwick Prodromos, M.D.","CONTACT","8476996810","care@thepsci.com",{"type":57,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100451409","phase-1-safety-of-cultured-allogeneic-adult-umbilical-cord-derived-mesenchymal-stem-cells-for-skin-ulcer-100451409",false,"NCT05158127","Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Skin Ulcer","Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Skin Ulcer","Inclusion Criteria:\n\n* Diagnosis of Skin Ulcer\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":67,"type":68},20,"ESTIMATED","INTERVENTIONAL",[71],"PHASE1","This trial will study the safety and efficacy of intravenous infusion and intralesional injection of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Skin Ulcer",[74],"Skin Ulcer",[74,76],"stem cell treatment","NOT_YET_RECRUITING","2025-04-15",{"date":80,"type":81},"2025-04-17","ACTUAL",{"date":83,"type":68},"2025-12",{"date":85,"type":68},"2028-12",{"name":5,"class":6},1]