[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100451407":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":90,"overallStatus":41,"whyStopped":13,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"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 intranasal instillation of cultured allogeneic adult umbilical cord derived mesenchymal stem cell (UC-MSC) exosomes for the treatment of Stroke. Patients will receive intranasal instillations between both nasal cavities of UC-MSC exosomes. The total dose will be 4 CC of AlloEx, approximately 800 billion exosomes, for each day. Patients will receive instillations on back-to-back days totaling 2 doses. 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 (AlloEx)","EXPERIMENTAL","Intranasal instillations of 4 CCs of AlloEx between both nasal cavaties, which is approximately 800 billion exosomes in total. Second dose of 4 CCs to be receive the following day.",[27],"Biological: AlloEx",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":13},"BIOLOGICAL","AlloEx","cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes",[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","100451407","phase-1-safety-of-cultured-allogeneic-adult-umbilical-cord-derived-mesenchymal-stem-cell-exosome-intranasal-instillations-for-stroke-100451407",false,"NCT05158101","Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Exosome Intranasal Instillations for Stroke","Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Exosome Intranasal Instillations for the Treatment of Stroke","Inclusion Criteria:\n\n* Diagnosis of Stroke\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},15,"ESTIMATED","INTERVENTIONAL",[86],"PHASE1","This trial will study the safety and efficacy of intranasal instillation of cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes for the treatment of Stroke",[89],"Stroke",[89,91],"stem cell treatment","2025-04-15",{"date":94,"type":95},"2025-04-17","ACTUAL",{"date":97,"type":95},"2022-02-01",{"date":99,"type":83},"2026-02",{"name":5,"class":6},2]