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

March 11, 2026 updated by: CellinCells

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

31

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
      • Seoul, South Korea
        • Samsung Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TRTP-101
High-dose TRTP-101
Biological: TRTP-101
Intradermal injection
Experimental: TRPT-101 (Low dose group)
In a split-face design, low-dose TRTP-101 is administered to one side of the face and placebo to the contralateral side.
Biological: TRTP-101
Intradermal injection
Placebo Comparator: Placebo (Low dose group)
In a split-face design, placebo is administered to one side of the face and low-dose TRTP-101 to the contralateral side.
Biological: Placebo
Intradermal injection
Experimental: TRPT-101 (High dose group)
In a split-face design, high-dose TRTP-101 is administered to one side of the face and placebo to the contralateral side.
Biological: TRTP-101
Intradermal injection
Placebo Comparator: Placebo (High dose group)
In a split-face design, placebo is administered to one side of the face and high-dose TRTP-101 to the contralateral side.
Biological: Placebo
Intradermal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
[Phase 1] Number of Subjects 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
within 4 weeks
[Phase 2] Proportion of subjects achieving ≥ 1-grade improvement from baseline in ASRS
Time Frame: 12, 24 weeks after treatment
Proportion of subjects with ≥ 1-grade improvement from baseline in ASRS (Acne Scar Rating Scale) at 12, 24 weeks after treatment, as assessed by independent reviewers using a standardized photoguide
12, 24 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
[Phase 2] Proportion of subjects achieving ≥ 1-grade improvement on the GAIS
Time Frame: 12, 24 weeks after treatment
Proportion of subjects with ≥ 1-point improvement from baseline on the GAIS (Global Aesthetic Improvement Scale) at 12, 24 weeks after treatment, as assessed by independent reviewers.
12, 24 weeks after treatment
[Phase 2] Distribution of subjects by treatment satisfaction score
Time Frame: 12, 24 weeks after treatment
Distribution of subjects by treatment satisfaction score at 12, 24 weeks after treatment, assessed using the Subject Acne Scar Self-Assessment Scale.
12, 24 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CellinCells

Investigators

  • Principal Investigator: Jonghee Lee, MD, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

August 1, 2029

Study Registration Dates

First Submitted

March 11, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • CIC101-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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