[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629422":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":37,"studyPopulation":24,"armGroups":38,"interventions":63,"overallOfficials":71,"centralContacts":76,"locations":82,"responsibleParty":92,"collaborators":24,"id":94,"slug":24,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":24,"eligibilityCriteria":99,"healthyVolunteers":100,"sex":101,"minAge":102,"maxAge":24,"enrollmentInfo":103,"targetDuration":24,"studyType":106,"phases":107,"briefSummary":110,"conditions":111,"keywords":24,"overallStatus":113,"whyStopped":24,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"CellinCells","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":24},[9,13],{"measure":10,"description":11,"timeFrame":12},"[Phase 1] Number of Subjects with Dose Limiting Toxicity","Dose Limiting Toxicity is defined as Grade ≥ 3 adverse drug reaction according to CTCAE criteria for 4 weeks after administration of TRTP-101","within 4 weeks",{"measure":14,"description":15,"timeFrame":16},"[Phase 2] Proportion of subjects achieving ≥ 1-grade improvement from baseline in ASRS","Proportion of subjects with ≥ 1-grade improvement from baseline in ASRS (Acne Scar Rating Scale) at 12, 24 weeks after treatment, as assessed by independent reviewers using a standardized photoguide","12, 24 weeks after treatment",[18,21],{"measure":19,"description":20,"timeFrame":16},"[Phase 2] Proportion of subjects achieving ≥ 1-grade improvement on the GAIS","Proportion of subjects with ≥ 1-point improvement from baseline on the GAIS (Global Aesthetic Improvement Scale) at 12, 24 weeks after treatment, as assessed by independent reviewers.",{"measure":22,"description":23,"timeFrame":16},"[Phase 2] Distribution of subjects by treatment satisfaction score","Distribution of subjects by treatment satisfaction score at 12, 24 weeks after treatment, assessed using the Subject Acne Scar Self-Assessment Scale.",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":24,"primaryPurpose":28,"observationalModel":24,"timePerspective":24,"maskingInfo":29},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":30,"maskingDescription":31,"whoMasked":32},"QUADRUPLE","The Phase 1 study is conducted as an open-label trial, whereas the Phase 2 study is designed as a randomized, double-blind trial.",[33,34,35,36],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","A phase 1 clinical trial designed to evaluate dose-limiting toxicity (DLT) following single-dose administration of TRTP-101 into four or more atrophic scar sites.\n\nSubsequently, a phase 2 clinical trial will be conducted using a placebo-controlled, split-face design to evaluate the safety and efficacy of TRTP-101. Eligible subjects will have atrophic scars approximately 2 cm in diameter located on both sides of the face (e.g., the cheek or temple areas), and TRTP-101 and placebo will be administered to the respective sides of the face.",[39,45,49,55,59],{"label":40,"type":41,"description":42,"interventionNames":43},"TRTP-101","EXPERIMENTAL","High-dose TRTP-101",[44],"Biological: TRTP-101",{"label":46,"type":41,"description":47,"interventionNames":48},"TRPT-101 (Low dose group)","In a split-face design, low-dose TRTP-101 is administered to one side of the face and placebo to the contralateral side.",[44],{"label":50,"type":51,"description":52,"interventionNames":53},"Placebo (Low dose group)","PLACEBO_COMPARATOR","In a split-face design, placebo is administered to one side of the face and low-dose TRTP-101 to the contralateral side.",[54],"Biological: Placebo",{"label":56,"type":41,"description":57,"interventionNames":58},"TRPT-101 (High dose group)","In a split-face design, high-dose TRTP-101 is administered to one side of the face and placebo to the contralateral side.",[44],{"label":60,"type":51,"description":61,"interventionNames":62},"Placebo (High dose group)","In a split-face design, placebo is administered to one side of the face and high-dose TRTP-101 to the contralateral side.",[54],[64,68],{"type":65,"name":40,"description":66,"armGroupLabels":67,"otherNames":24},"BIOLOGICAL","Intradermal injection",[56,46,40],{"type":65,"name":69,"description":66,"armGroupLabels":70,"otherNames":24},"Placebo",[60,50],[72],{"name":73,"affiliation":74,"role":75},"Jonghee Lee, MD","Samsung Medical Center","PRINCIPAL_INVESTIGATOR",[77],{"name":78,"role":79,"phone":80,"phoneExt":24,"email":81},"HyeJung Park","CONTACT","+82-70-4469-9115","hjpark@cellincells.com",[83],{"facility":74,"status":24,"city":84,"state":24,"zip":24,"country":85,"countryCode":24,"cosmosGeoPoint":86,"geoPoint":91,"contacts":24},"Seoul","South Korea",{"type":87,"coordinates":88},"Point",[89,90],126.9784,37.566,{"lat":90,"lon":89},{"type":93,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100629422",false,"NCT07474467","Safety and Efficacy of Autologous Adipose-derived Mesenchymal Stem Cells Therapy in Adults With Atrophic Scars","A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Split-Face, Phase 1\u002F2 Study to Evaluate the Safety and Efficacy of a Single Administration of TRTP-101 in Adults With Atrophic Scars","Inclusion Criteria:\n\n* Male or Female aged greater than 19 years\n* Acne scars graded ≥ 3 on the 5-point ASRS\n\n\\[Phase 1\\]\n\n* Four or more atrophic scars in the joints, genitals, perineum, and face except for the lips, eyes and nose\n\n\\[Phase 2\\]\n\n* Atrophic scar lesions approximately 2 cm in diameter located on the cheeks or temple on both sides of the face\n* A response of \"dissatisfied\" or worse on the Subject Acne Scar Self-Assessment Scale\n\nExclusion Criteria:\n\n* History of cell therapy\n* Treatment of Dermal resurfacing, Chemical\u002FMechanical Peel and Skin Photorejuvenation\n* Treatment of Hyaluronic acid\u002Fcollagen skin filler, non-permanent soft tissue filler and fat grafting\n* Positive for virus infection\n* Use of Anticoagulant therapy or NSAIDs\n* Thrombocytopenia or other coagulation disorder\n* History of keloid scars\n* Infectious disease or other dermatitis in the area of the atrophic scar\n* Use of Immunosuppressant, immunomodulating drug, anticancer drug or radiation therapy\n* Use of systemic steroid medication\n* History of hypersensitivity or severe allergic reactions (e.g., anaphylaxis, Guillain-Barre syndrome, etc.)\n* Use of retinoid medications",true,"ALL","19 Years",{"count":104,"type":105},31,"ESTIMATED","INTERVENTIONAL",[108,109],"PHASE1","PHASE2","The purpose of this clinical trial was to evaluate the safety and efficacy of a single administration of TRTP-101 in adults with atrophic scars.",[112],"Atrophic Scar","NOT_YET_RECRUITING","2026-03-11",{"date":116,"type":117},"2026-03-16","ACTUAL",{"date":119,"type":105},"2026-08-01",{"date":121,"type":105},"2029-08-01",{"name":5,"class":6},1]