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 1/2 Study to Evaluate the Safety and Efficacy of a Single Administration of TRTP-101 in Adults With Atrophic Scars

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.

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.

Subsequently, 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.

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