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Safety and Efficacy of Autologous Adipose-derived Mesenchymal Stem Cells Therapy in Adults With Atrophic Scars

RecruitingPhase 1, Phase 2

Sponsor: CellinCells

Conditions: Atrophic Scar

Interventions: TRTP-101, Placebo

Countries: South Korea

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 overview

Sex: ALL

Age: 19 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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

Locations (1)

Seoul, South Korea