Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:38 AM
Study NCT ID:
NCT07474467
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Autologous Adipose-derived Mesenchymal Stem Cells Therapy in Adults With Atrophic Scars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The Phase 1 study is conducted as an open-label trial, whereas the Phase 2 study is designed as a randomized, double-blind trial.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 31}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2029-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-03-11', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '[Phase 1] Number of Subjects with Dose Limiting Toxicity', 'timeFrame': 'within 4 weeks', 'description': 'Dose Limiting Toxicity is defined as Grade ≥ 3 adverse drug reaction according to CTCAE criteria for 4 weeks after administration of TRTP-101'}, {'measure': '[Phase 2] Proportion of subjects achieving ≥ 1-grade improvement from baseline in ASRS', 'timeFrame': '12, 24 weeks after treatment', 'description': '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'}], 'secondaryOutcomes': [{'measure': '[Phase 2] Proportion of subjects achieving ≥ 1-grade improvement on the GAIS', 'timeFrame': '12, 24 weeks after treatment', 'description': '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': '[Phase 2] Distribution of subjects by treatment satisfaction score', 'timeFrame': '12, 24 weeks after treatment', 'description': 'Distribution of subjects by treatment satisfaction score at 12, 24 weeks after treatment, assessed using the Subject Acne Scar Self-Assessment Scale.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrophic Scar']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '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/Mechanical Peel and Skin Photorejuvenation\n* Treatment of Hyaluronic acid/collagen 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'}, 'identificationModule': {'nctId': 'NCT07474467', 'briefTitle': 'Safety and Efficacy of Autologous Adipose-derived Mesenchymal Stem Cells Therapy in Adults With Atrophic Scars', 'organization': {'class': 'INDUSTRY', 'fullName': 'CellinCells'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Split-Face, Phase 1/2 Study to Evaluate the Safety and Efficacy of a Single Administration of TRTP-101 in Adults With Atrophic Scars', 'orgStudyIdInfo': {'id': 'CIC101-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TRTP-101', 'description': 'High-dose TRTP-101', 'interventionNames': ['Biological: TRTP-101']}, {'type': 'EXPERIMENTAL', 'label': 'TRPT-101 (Low dose group)', 'description': 'In a split-face design, low-dose TRTP-101 is administered to one side of the face and placebo to the contralateral side.', 'interventionNames': ['Biological: TRTP-101']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Low dose group)', 'description': 'In a split-face design, placebo is administered to one side of the face and low-dose TRTP-101 to the contralateral side.', 'interventionNames': ['Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'TRPT-101 (High dose group)', 'description': 'In a split-face design, high-dose TRTP-101 is administered to one side of the face and placebo to the contralateral side.', 'interventionNames': ['Biological: TRTP-101']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (High dose group)', 'description': 'In a split-face design, placebo is administered to one side of the face and high-dose TRTP-101 to the contralateral side.', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'TRTP-101', 'type': 'BIOLOGICAL', 'description': 'Intradermal injection', 'armGroupLabels': ['TRPT-101 (High dose group)', 'TRPT-101 (Low dose group)', 'TRTP-101']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Intradermal injection', 'armGroupLabels': ['Placebo (High dose group)', 'Placebo (Low dose group)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'HyeJung Park', 'role': 'CONTACT', 'email': 'hjpark@cellincells.com', 'phone': '+82-70-4469-9115'}], 'overallOfficials': [{'name': 'Jonghee Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CellinCells', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}