[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594024":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":27,"responsibleParty":47,"collaborators":51,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":11,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":11,"enrollmentInfo":64,"targetDuration":11,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":79,"overallStatus":85,"whyStopped":11,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University of Sao Paulo General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Production of autologous serum in a closed system for ocular use","EXPERIMENTAL",null,[13],"Drug: Autologous Serum 20%",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","Autologous Serum 20%","The collection of autologous serum in a closed blood processing system for ocular use",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":25,"email":26},"Giancarlo Fatobene, MD, PhD","CONTACT","+55 (11) 2661-9559","9559","giancarlo.fatobene@hc.fm.usp.br",[28],{"facility":29,"status":11,"city":30,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"HCFMUSP","São Paulo","05410020","Brazil","BR",{"type":35,"coordinates":36},"Point",[37,38],-46.63611,-23.5475,{"lat":38,"lon":37},[41,45],{"name":42,"role":23,"phone":43,"phoneExt":11,"email":44},"Victoria Sousa","+55 11 95955-4850","pesquisa.hematologia@hc.fm.usp.br",{"name":22,"role":46,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","GIANCARLO FATOBENE","MD, PhD",[52],{"name":53,"class":54},"JP Farma","UNKNOWN","100594024","phase-2-autologous-serum-obtained-by-a-closed-circuit-collection-device-100594024",false,"NCT07014059","Autologous Serum Obtained by a Closed-Circuit Collection Device","\"In Vivo Evaluation of Topical Ocular Use of Autologous Serum Obtained by a Closed-Circuit Collection Device.\"","Inclusion Criteria:\n\n* ≥ 18 years\n* Dry eye and\u002For chronic epithelial defects of the ocular surface with indication for autologous serum according to the evaluation of ophthalmologists specialized in Cornea and Ocular Surface;\n* Peripheral venous access or PICC that allows the collection of whole blood.\n\nExclusion Criteria:\n\n* Active ocular infection;\n* Hemoglobin \\\u003C 11 g\u002FdL;\n* Angina, MI, or stroke in the last 30 days;\n* Significant pulmonary or cardiac disease that contraindicates autologous serum collection in the investigator's opinion;\n* Active ocular or systemic infection at the time of collection;\n* Inability to attend follow-up visits at 6 and 12 weeks;\n* Active hematological malignancy (except measurable residual disease) or solid malignancy (except non-melanoma skin cancer);\n* Positive for HIV, HCV, HBV, HTLV, Chagas disease, or syphilis;\n* Life expectancy \\\u003C 6 months;\n* Not pregnant (as reported by the participant).","ALL","18 Years",{"count":65,"type":66},16,"ESTIMATED","INTERVENTIONAL",[69],"PHASE2","Autologous serum eye drops (ASED) are an established therapy for ocular surface diseases; however, their preparation can be costly and may not be available due to the need for germ-free conditions. This pilot trial assesses the feasibility of collecting ASED in a closed-circuit system for patients with chronic ocular surface diseases.",[72,73,74,75,76,77,78],"GVHD","Meibomian Gland Dysfunction (Disorder)","Stevens-Johnson Syndrome","Limbal Keratoconjunctivitis","Recurrent Erosions of Persistent Epithelial Defects","Neurotrophic Ulcer","Sjogren Syndrome With Keratoconjunctivitis",[80,81,82,73,74,75,77,76,83,84],"soro autologo","gvhd","Sjogren's Syndrome (SS)","Study Protocol - Autologous Serum","Autologous Serum","NOT_YET_RECRUITING","2025-06-02",{"date":88,"type":89},"2025-06-10","ACTUAL",{"date":91,"type":66},"2025-06-20",{"date":93,"type":66},"2027-06-20",{"name":49,"class":6},1]