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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06210919

Enrollment

Registered

2024-01-18

Start date

2023-12-06

Completion date

2025-03-28

Last updated

2025-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrophic Scar

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.

Interventions

BIOLOGICALTRTP-101

Intradermal injection of the each of four sites

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Male or Female aged greater than 19 years 2. Four or more atrophic scars in the joints, genitals, perineum, and face except for the lips, eyes and nose

Exclusion criteria

1. History of cell therapy 2. Treatment of Dermal resurfacing, Chemical/Mechanical Peel and Skin Photorejuvenation 3. Treatment of Hyaluronic acid/collagen skin filler, non-permanent soft tissue filler and fat grafting 4. Positive for virus infection 5. Use of Anticoagulant therapy or NSAIDs 6. Thrombocytopenia or other coagulation disorder 7. History of keloid scars 8. Infectious disease or other dermatitis in the area of the atrophic scar 9. Use of Immunosuppressant, immunomodulating drug, anticancer drug or radiation therapy 10. Use of systemic steroid medication 11. History of hypersensitivity or severe allergic reactions (e.g., anaphylaxis, Guillain-Barre syndrome, etc.) 12. Use of retinoid medications

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants with Dose Limiting Toxicity	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

Measure	Time frame	Description
Mean percent change in atrophic scar volume	1, 4, 8 and 12 weeks	The depressed volume of atropic scar is measured at baseline and post-treatment visits

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026