[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509135":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":29,"centralContacts":41,"locations":49,"responsibleParty":72,"collaborators":24,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":24,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":24,"studyType":87,"phases":88,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":99,"whyStopped":24,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"PT. Prodia Stem Cell Indonesia","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"EYESTEM 001-X","EXPERIMENTAL","1.8 ml cell preparations are suspended in Conditioned Media (CM) until it reaches a 2 ml volume of cell suspension. Umbilical Cord Mesenchymal Stem Cell (UC-MSC) suspension will be injected into the peribulbar.",[13],"Biological: 1.5 x 10^6 UC-MSC + CM",{"label":15,"type":10,"description":11,"interventionNames":16},"EYESTEM 001-XF",[17],"Biological: 5 x 10^6 UC-MSC + CM",[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"BIOLOGICAL","1.5 x 10^6 UC-MSC + CM","1.5 million cells of UC-MSC in 2 ml of Conditioned Medium (CM)",[9],null,{"type":20,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"5 x 10^6 UC-MSC + CM","5 million cells of UC-MSC in 2 ml of Conditioned Medium (CM)",[15],[30,34,38],{"name":31,"affiliation":32,"role":33},"dr. Muhammad B Sasongko, Sp.M, M.Epid, PhD","Gadjah Mada University, Faculty of Medicine","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":36,"role":37},"Cosmos Mangunsong, Doctor","Jakarta Eye Center","STUDY_CHAIR",{"name":39,"affiliation":40,"role":37},"dr. Rifa Widyaningrum, M.Sc, PhD","Sardjito Hospital",[42,46],{"name":31,"role":43,"phone":44,"phoneExt":24,"email":45},"CONTACT","+62811293476","mb.sasongko@ugm.ac.id",{"name":47,"role":43,"phone":24,"phoneExt":24,"email":48},"Dr. Cynthia R Sartika, M.Si","cynthia.sartika@prostem.co.id",[50],{"facility":51,"status":24,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RSUP Dr. Sardjito","Yogyakarta","DI Yogyakarta","55284","Indonesia","ID",{"type":58,"coordinates":59},"Point",[60,61],110.36472,-7.80139,{"lat":61,"lon":60},[64,67,69],{"name":65,"role":43,"phone":66,"phoneExt":24,"email":24},"Rifa Widyaningrum, PhD","082134546400",{"name":68,"role":33,"phone":24,"phoneExt":24,"email":24},"Bayu Sasongko, PhD",{"name":70,"role":71,"phone":24,"phoneExt":24,"email":24},"Cosmos Mangunsong, Dr","SUB_INVESTIGATOR",{"type":73,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100509135","phase-2-role-of-uc-msc-and-cm-to-inhibit-vision-loss-in-retinitis-pigmentosa-phase-iii-100509135",false,"NCT05909488","Role of UC-MSC and CM to Inhibit Vision Loss in Retinitis Pigmentosa Phase I\u002FII","Role of Umbilical Cord-derived Stem Cell Transplantation and Conditioned Medium to Inhibit Vision Loss in Retinitis Pigmentosa Phase I\u002FII","Inclusion Criteria:\n\n* Visus more than 20\u002F100\n* Have more than 0.68 uV on conical receptor cell amplitude checked by ERG\n* Visual field equivalent diameter more than 10o\n* Willing to sign informed consent as research subjects\n* Willing to do the peribulbar injection with mesenchymal stem cells isolated from umbilical cord tissue\n* Willing to do visual field checks with Humphrey's perimetry, vision tests with Snellen boards, Optical Coherent Tomography (OCT) examinations, electroretinogram examinations, and fill out a quality of life questionnaire\n\nExclusion Criteria:\n\n* Pregnant or nursing women\n* Positive result of HIV test\n* Have a history of eye tumors\n* Under immunosuppressive treatment or other drugs that can affect the growth of transplanted stem cells\n* Have another eye disease such as diabetic retinopathy, uveitis, cataract, and glaucoma\n* Do not come to control according to the schedule determined by the researcher (loss to follow up)","ALL","18 Years","65 Years",{"count":85,"type":86},30,"ESTIMATED","INTERVENTIONAL",[89,90],"PHASE2","PHASE3","The study will perform UC-MSCs and CM transplantation. There are two groups with different dosages. The first group will be transplanted with 1.5 million cells, meanwhile, the second group is 5 million cells. Each group consists of 30 subjects. All groups will be transplanted via the peribulbar route. All groups will be observed until six months.",[93],"Retinitis Pigmentosa",[95,96,97,98],"Allogeneic Mesenchymal Stem Cell","Umbilical Cord Mesenchymal Stem Cell","Conditioned Medium","Allogeneic Umbilical Cord Mesenchymal Stem Cell","NOT_YET_RECRUITING","2026-02-23",{"date":102,"type":103},"2026-02-25","ACTUAL",{"date":105,"type":86},"2026-05",{"date":107,"type":86},"2027-09",{"name":5,"class":6},1]