[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100440554":3},{"organization":4,"outcomesModule":7,"designInfo":20,"detailedDescription":26,"studyPopulation":19,"armGroups":27,"interventions":34,"overallOfficials":40,"centralContacts":19,"locations":44,"responsibleParty":77,"collaborators":19,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":19,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":19,"maxAge":19,"enrollmentInfo":87,"targetDuration":19,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":47,"whyStopped":19,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"The Foundation for Orthopaedics and Regenerative Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":19},[9],{"measure":10,"description":11,"timeFrame":12},"Safety (adverse events)","Clinical monitoring of possible adverse events or complications","Four year follow-up",[14,17],{"measure":15,"description":16,"timeFrame":12},"Efficacy: skin score","It will be completed for each follow up point.",{"measure":18,"description":16,"timeFrame":12},"Efficacy: Forced vital capacity (FVC)",null,{"allocation":21,"interventionModel":22,"interventionModelDescription":19,"primaryPurpose":23,"observationalModel":19,"timePerspective":19,"maskingInfo":24},"NA","SINGLE_GROUP","TREATMENT",{"masking":25,"maskingDescription":19,"whoMasked":19},"NONE","Studies have shown that stem cell treatment is safe and efficacious for the treatment of Systemic Sclerosis. Patients with Systemic Sclerosis will receive a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. 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.\n\nFor patients with more severe disease requiring chemotherapeutic drugs such as methotrexate, an autologous T Cell vaccine will be utilized created from the patient's own T cells obtained by apheresis.",[28],{"label":29,"type":30,"description":31,"interventionNames":32},"Treatment Group","EXPERIMENTAL","Single intravenous infusion of 100 million cells",[33],"Biological: AlloRx",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":19},"BIOLOGICAL","AlloRx","cultured allogeneic adult umbilical cord derived mesenchymal stem cells",[29],[41],{"name":42,"affiliation":5,"role":43},"Chadwick Prodromos, MD","PRINCIPAL_INVESTIGATOR",[45,63],{"facility":46,"status":47,"city":48,"state":19,"zip":19,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Medical Surgical Associates Center","RECRUITING","St John's","Antigua and Barbuda","AG",{"type":52,"coordinates":53},"Point",[54,55],-61.84329,17.12096,{"lat":55,"lon":54},[58],{"name":59,"role":60,"phone":61,"phoneExt":19,"email":62},"Chadwick Prodromos, M.D.","CONTACT","8476996810","care@thepsci.com",{"facility":64,"status":47,"city":65,"state":19,"zip":19,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Center for Investigation in Tissue Engineering and Cellular Therapy","Buenos Aires","Argentina","AR",{"type":52,"coordinates":69},[70,71],-58.37723,-34.61315,{"lat":71,"lon":70},[74],{"name":59,"role":60,"phone":61,"phoneExt":75,"email":76},"202","Care@thepsci.com",{"type":78,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100440554","phase-1-safety-of-cultured-allogeneic-adult-umbilical-cord-derived-mesenchymal-stem-cell-iv-infusion-for-systemic-sclerosis-100440554",false,"NCT05016804","Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell IV Infusion for Systemic Sclerosis","Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Systemic Sclerosis","Inclusion Criteria:\n\n* Diagnosis of Systemic Sclerosis\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":88,"type":89},20,"ESTIMATED","INTERVENTIONAL",[92],"PHASE1","This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Systemic Sclerosis",[95],"Systemic Sclerosis",[95,97,98],"Scleroderma","stem cell treatment","2025-04-04",{"date":101,"type":102},"2025-04-08","ACTUAL",{"date":104,"type":102},"2022-07-04",{"date":106,"type":89},"2026-11",{"name":5,"class":6},2]