[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100410662":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":39,"locations":45,"responsibleParty":84,"collaborators":86,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":27,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":106,"maxAge":27,"enrollmentInfo":107,"targetDuration":27,"studyType":110,"phases":111,"briefSummary":114,"conditions":115,"keywords":27,"overallStatus":48,"whyStopped":27,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Luxa Biotechnology, LLC","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"50,000 cells","EXPERIMENTAL","Six patients will receive single dose of 50,000 RPESC-RPE-4W cells in the eye.",[13],"Biological: RPESC-RPE-4W",{"label":15,"type":10,"description":16,"interventionNames":17},"150,000 cells","Six patients will receive single dose of 150,000 RPESC-RPE-4W cells in the eye.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"250,000 cells","Six patients will receive single dose of 250,000 RPESC-RPE-4W cells in the eye.",[13],[23],{"type":24,"name":25,"description":25,"armGroupLabels":26,"otherNames":27},"BIOLOGICAL","RPESC-RPE-4W",[15,19,9],null,[29,33,36],{"name":30,"affiliation":31,"role":32},"Rajesh C Rao, M.D.","University of Michigan Kellogg Eye Center","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":35,"role":32},"Theodore Leng, MD, FACS","Spencer Center for Vision Research at Stanford University",{"name":37,"affiliation":38,"role":32},"David S Liao, MD, PhD","Retina-Vitreous Associates Medical Group",[40],{"name":41,"role":42,"phone":43,"phoneExt":27,"email":44},"Jeffrey H Stern, M.D., Ph.D.","CONTACT","05184371111","jeffreystern@luxabiotech.com",[46,62,73],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Retina Vitreous Associates Medical Group","RECRUITING","Beverly Hills","California","90211","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-118.40036,34.07362,{"lat":58,"lon":57},[61],{"name":37,"role":42,"phone":27,"phoneExt":27,"email":27},{"facility":63,"status":48,"city":64,"state":50,"zip":65,"country":52,"countryCode":53,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Spencer Center for Vision Research","Palo Alto","94303",{"type":55,"coordinates":67},[68,69],-122.14302,37.44188,{"lat":69,"lon":68},[72],{"name":34,"role":42,"phone":27,"phoneExt":27,"email":27},{"facility":31,"status":48,"city":74,"state":75,"zip":76,"country":52,"countryCode":53,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Ann Arbor","Michigan","48105",{"type":55,"coordinates":78},[79,80],-83.74088,42.27756,{"lat":80,"lon":79},[83],{"name":30,"role":42,"phone":27,"phoneExt":27,"email":27},{"type":85,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[87,90,92,95],{"name":88,"class":89},"National Institutes of Health (NIH)","NIH",{"name":91,"class":89},"National Eye Institute (NEI)",{"name":93,"class":94},"Regenerative Research Foundation","UNKNOWN",{"name":96,"class":97},"California Institute for Regenerative Medicine (CIRM)","OTHER","100410662","phase-1-safety-and-tolerability-of-rpe-stem-cell-derived-rperpesc-rpe-transplantation-in-patients-with-dry-age-related-macular-degeneration-amd-100410662",false,"NCT04627428","Safety and Tolerability of RPE Stem Cell-derived RPE(RPESC-RPE) Transplantation in Patients With Dry Age-related Macular Degeneration (AMD)","A Phase1\u002F2a, Open-Label Study to Evaluate the Safety and Tolerability of RPE Stem Cell-derived RPE (RPESC-RPE) Transplantation as Therapy for Dry Age-related Macular Degeneration (AMD)","Inclusion Criteria:\n\n1. Clinical diagnosis of dry AMD.\n2. Ability to understand and give informed consent.\n3. Adult male or female \\>55 years of age.\n4. Medically suitable to undergo vitrectomy and subretinal injection (\\>60% on Karnofsky scale).\n5. Postmenopausal if female (expected to be common for the age limitation), or the female partner of a male subject unable to father children.\n6. If male, willing to use barrier and spermicidal contraception during the study.\n\nExclusion Criteria:\n\n1. Allergy or hypersensitivity to dilation drops or fluorescein.\n2. Active major medical conditions limiting ability to participate in the study.\n3. Active malignancy or treatment with chemotherapy.\n4. Systemic immunosuppressant therapy within past six months.\n5. History of toxoplasmosis, retinal histoplasmosis or tuberculosis.\n6. Receipt of investigational product (IP) in a clinical trial within prior six months.\n7. Any other medical condition, which, in the Investigator's judgment, will interfere with the subject's ability to comply with the protocol, compromises subject safety, or interferes with the interpretation of the study results.\n8. Pregnant or nursing females.","ALL","55 Years",{"count":108,"type":109},18,"ESTIMATED","INTERVENTIONAL",[112,113],"PHASE1","PHASE2","The main objective of the study is evaluation of the safety and tolerability of RPESC-RPE-4W as therapy for dry AMD.",[116],"Dry Age-related Macular Degeneration","2025-10-12",{"date":119,"type":120},"2025-10-15","ACTUAL",{"date":122,"type":120},"2022-04-05",{"date":124,"type":109},"2026-12-01",{"name":5,"class":6},3]