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

NCT07474467 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: CIC101-02
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrophic Scar

Outcome Measures

Primary Outcomes (2)

• [Phase 1] Number of Subjects with Dose Limiting Toxicity

  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

  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 Outcomes (2)

• [Phase 2] Proportion of subjects achieving ≥ 1-grade improvement on the GAIS

  12, 24 weeks after treatment

• [Phase 2] Distribution of subjects by treatment satisfaction score

  12, 24 weeks after treatment

Study Arms (5)

TRTP-101

EXPERIMENTAL

High-dose TRTP-101

Biological: TRTP-101

TRPT-101 (Low dose group)

EXPERIMENTAL

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

Placebo (Low dose group)

PLACEBO COMPARATOR

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

TRPT-101 (High dose group)

EXPERIMENTAL

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

Placebo (High dose group)

PLACEBO COMPARATOR

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

Interventions

TRTP-101 BIOLOGICAL

Intradermal injection

TRPT-101 (High dose group); TRPT-101 (Low dose group); TRTP-101

Placebo BIOLOGICAL

Intradermal injection

Placebo (High dose group); Placebo (Low dose group)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CellinCells: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Study Officials

• Jonghee Lee, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

HyeJung Park

CONTACT

+82-70-4469-9115; hjpark@cellincells.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Phase 1 study is conducted as an open-label trial, whereas the Phase 2 study is designed as a randomized, double-blind trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 16, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)