[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100450968":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":28,"overallOfficials":34,"centralContacts":13,"locations":38,"responsibleParty":57,"collaborators":13,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":13,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":13,"maxAge":13,"enrollmentInfo":67,"targetDuration":13,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":41,"whyStopped":13,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"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 installation of cultured allogeneic adult umbilical cord derived mesenchymal stem cell (UC-MSC) exosomes for the treatment of Parkinson's Disease. Patients will receive a dose of 4 CCs of AlloEx, approximately 800 billion exosomes, between both nasal cavities. A second equivalent dose will be administered on the subsequent day. 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 (AlloEx)","EXPERIMENTAL","Intranasal instillations of 4 CCs of AlloEx, approximately 800 billion exosomes. Treatments on back-to-back days, totaling 2 doses.",[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],{"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",{"type":58,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100450968","phase-1-safety-of-cultured-allogeneic-adult-umbilical-cord-derived-mesenchymal-stem-cell-exosomes-for-parkinsons-disease-100450968",false,"NCT05152394","Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Exosomes for Parkinson's Disease","Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Exosome Intranasal Instillation for the Treatment of Parkinson's Disease","Inclusion Criteria:\n\n* Diagnosis of Parkinson's Disease\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\n* Anticoagulation medicine use","ALL",{"count":68,"type":69},20,"ESTIMATED","INTERVENTIONAL",[72],"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 Parkinson's Disease",[75],"Parkinson Disease",[77,78],"Parkinson's Disease","stem cell treatment","2025-04-15",{"date":81,"type":82},"2025-04-17","ACTUAL",{"date":84,"type":82},"2024-08-17",{"date":86,"type":69},"2027-01",{"name":5,"class":6},1]