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OpenTrials
Completed

NCT Number: NCT06210919

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

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.

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Key information

Conditions

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Samsung Medical Center

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • History of hypersensitivity or severe allergic reactions (e.g., anaphylaxis, Guillain-Barre syndrome, etc.)
  • Use of retinoid medications

Treatment and study plan

TRTP-101

Biological

Intradermal injection of the each of four sites

Primary outcomes

  1. 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

  1. Mean percent change in atrophic scar volume

    Time frame: 1, 4, 8 and 12 weeks

    The depressed volume of atropic scar is measured at baseline and post-treatment visits

Sponsors and collaborators

Lead sponsor

CellinCells

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jan 18, 2024
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.