[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100450608":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":28,"overallOfficials":34,"centralContacts":13,"locations":38,"responsibleParty":71,"collaborators":13,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":13,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":13,"maxAge":13,"enrollmentInfo":81,"targetDuration":13,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":95,"overallStatus":41,"whyStopped":13,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"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 and sub-tenon delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of non-arteritic ischemic optic neuropathy. 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 an autologous Effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis.",[22],{"label":23,"type":24,"description":25,"interventionNames":26},"Treatment Group (AlloRx)","EXPERIMENTAL","intravenous and sub-tenon delivery (total dose 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",[39,57],{"facility":40,"status":41,"city":42,"state":13,"zip":13,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Medical Surgical Associates Center","RECRUITING","St John's","Antigua and Barbuda","AG",{"type":46,"coordinates":47},"Point",[48,49],-61.84329,17.12096,{"lat":49,"lon":48},[52],{"name":53,"role":54,"phone":55,"phoneExt":13,"email":56},"Chadwick Prodromos, M.D.","CONTACT","8476996810","care@thepsci.com",{"facility":58,"status":41,"city":59,"state":13,"zip":13,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Center for Investigation in Tissue Engineering and Cellular Therapy","Buenos Aires","Argentina","AR",{"type":46,"coordinates":63},[64,65],-58.37723,-34.61315,{"lat":65,"lon":64},[68],{"name":53,"role":54,"phone":55,"phoneExt":69,"email":70},"202","Care@thepsci.com",{"type":72,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100450608","phase-1-safety-of-cultured-allogeneic-adult-umbilical-cord-derived-mesenchymal-stem-cells-for-naion-100450608",false,"NCT05147701","Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for NAION","Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Non-arteritic Ischemic Optic Neuropathy","Inclusion Criteria:\n\n* Diagnosis of NAION (non-arteritic ischemic optic neuropathy)\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":82,"type":83},20,"ESTIMATED","INTERVENTIONAL",[86],"PHASE1","This trial will study the safety and efficacy of intravenous and sub-tenon delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of non-arteritic ischemic optic neuropathy",[89,90,91,92,93,94],"Eye Diseases","Retinitis Pigmentosa","Diabetic Retinopathy","Macular Degeneration","Traumatic Optic Neuropathy","Optic Atrophy",[89,90,96,91,92,93,94],"stem cell treatment","2025-04-15",{"date":99,"type":100},"2025-04-17","ACTUAL",{"date":102,"type":100},"2022-02-01",{"date":104,"type":83},"2026-01",{"name":5,"class":6},2]