[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509135":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":29,"centralContacts":41,"locations":49,"responsibleParty":71,"collaborators":24,"id":73,"slug":24,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":24,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":24,"studyType":85,"phases":86,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":97,"whyStopped":24,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"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,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"RSUP Dr. Sardjito","Yogyakarta","DI Yogyakarta","55284","Indonesia",{"type":57,"coordinates":58},"Point",[59,60],110.36472,-7.80139,{"lat":60,"lon":59},[63,66,68],{"name":64,"role":43,"phone":65,"phoneExt":24,"email":24},"Rifa Widyaningrum, PhD","082134546400",{"name":67,"role":33,"phone":24,"phoneExt":24,"email":24},"Bayu Sasongko, PhD",{"name":69,"role":70,"phone":24,"phoneExt":24,"email":24},"Cosmos Mangunsong, Dr","SUB_INVESTIGATOR",{"type":72,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","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":83,"type":84},30,"ESTIMATED","INTERVENTIONAL",[87,88],"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.",[91],"Retinitis Pigmentosa",[93,94,95,96],"Allogeneic Mesenchymal Stem Cell","Umbilical Cord Mesenchymal Stem Cell","Conditioned Medium","Allogeneic Umbilical Cord Mesenchymal Stem Cell","NOT_YET_RECRUITING","2026-02-23",{"date":100,"type":101},"2026-02-25","ACTUAL",{"date":103,"type":84},"2026-05",{"date":105,"type":84},"2027-09",{"name":5,"class":6},1]