NCT06210919
Completed
Phase 1
A Phase 1, Single-Center, Single-Arm, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Single Dose of TRTP-101 in Adults With Atrophic Scars
Overview
- Phase
- Phase 1
- Intervention
- TRTP-101
- Conditions
- Atrophic Scar
- Sponsor
- CellinCells
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Number of Participants with Dose Limiting Toxicity
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
The purpose of this clinical trial was to evaluate the safety and tolerability for 12 weeks after one dose of TRTP-101 in adults with atrophic scars.
Detailed Description
A phase 1 clinical trial to evaluate dose-limiting toxicity by administering a singe dose of TRTP-101 to each of the four sites of atrophic scar.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or Female aged greater than 19 years
- •Four or more atrophic scars in the joints, genitals, perineum, and face except for the lips, eyes and nose
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
Arms & Interventions
TRTP-101
Micro-Block (MiB) manufactured from autologous Adipose-derived Mesenchymal Stem Cells
Intervention: TRTP-101
Outcomes
Primary Outcomes
Number of Participants with Dose Limiting Toxicity
Time Frame: within 4 weeks
Dose Limiting Toxicity is defined as Grade ≥ 3 adverse drug reaction according to CTCAE criteria for 4 weeks after administration of TRTP-101
Secondary Outcomes
- Mean percent change in atrophic scar volume(1, 4, 8 and 12 weeks)
Study Sites (1)
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