Safety and Efficacy of Autologous Adipose-derived Mesenchymal Stem Cells Therapy in Adults With Atrophic Scars
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TRTP-101, Placebo.
- Who it may be relevant to
- Registry conditions: Atrophic Scar. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
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.
Interventions
- Biological TRTP-101
Intradermal injection - Biological Placebo
Intradermal injection
Primary outcome measures
- [Phase 1] Number of Subjects with Dose Limiting Toxicity [Time frame: within 4 weeks]
- [Phase 2] Proportion of subjects achieving ≥ 1-grade improvement from baseline in ASRS [Time frame: 12, 24 weeks after treatment]
Secondary outcome measures (2)
- [Phase 2] Proportion of subjects achieving ≥ 1-grade improvement on the GAIS [Time frame: 12, 24 weeks after treatment]
- [Phase 2] Distribution of subjects by treatment satisfaction score [Time frame: 12, 24 weeks after treatment]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Samsung Medical Center — Seoul
Identifiers
NCT: NCT07474467 · CIC101-02