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NCT07474467
Safety and Efficacy of Autologous Adipose-derived Mesenchymal Stem Cells Therapy in Adults With Atrophic Scars
Conditions: Atrophic Scar
Sex: All
Ages: 19 Years – N/A
Healthy volunteers: Yes
Phase: PHASE1, PHASE2
Enrollment: 31
Sponsor: CellinCells
Location: Samsung Medical Center Seoul
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Male or Female aged greater than 19 years
* Acne scars graded ≥ 3 on the 5-point ASRS
\[Phase 1\]
* Four or more atrophic scars in the joints, genitals, perineum, and face except for the lips, eyes and nose
\[Phase 2\]
* Atrophic scar lesions approximately 2 cm in diameter located on the cheeks or temple on both sides of the face
* A response of "dissatisfied" or worse on the Subject Acne Scar Self-Assessment Scale
Exclusion Criteria:
* History of cell therapy
* Treatment of Dermal resurfacing, Chemical/Mechanical Peel and Skin Photorejuvenation
* Treatment of Hyaluronic acid/collagen skin filler, non-permanent soft tissue filler and fat grafting
* Positive for virus infection
* Use of Anticoagulant therapy or NSAIDs
* Thrombocytopenia or other coagulation disorder
* History of keloid scars
* Infectious disease or other dermatitis in the area of the atrophic scar
* Use of Immunosuppressant, immunomodulating drug, anticancer drug or radiation therapy
* Use of systemic steroid medication
* History of hypersensitivity or severe allergic reactions (e.g., anaphylaxis, Guillain-Barre syndrome, etc.)
* Use of retinoid medications
Source: ClinicalTrials.gov (NCT07474467). StuddyBuddy aggregates publicly available trial information.