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

NCT06210919 | Completed Phase 1

• 1 other identifier: CIC101-01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrophic Scar

Outcome Measures

Primary Outcomes (1)

• Number of Participants 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

Secondary Outcomes (1)

• Mean percent change in atrophic scar volume

  1, 4, 8 and 12 weeks

Study Arms (1)

TRTP-101

EXPERIMENTAL

Micro-Block (MiB) manufactured from autologous Adipose-derived Mesenchymal Stem Cells

Biological: TRTP-101

Interventions

TRTP-101 BIOLOGICAL

Intradermal injection of the each of four sites

TRTP-101

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
• Four or more atrophic scars in the joints, genitals, perineum, and face except for the lips, eyes and nose

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

Related Publications (3)

• Kwon HH, Yang SH, Lee J, Park BC, Park KY, Jung JY, Bae Y, Park GH. Combination Treatment with Human Adipose Tissue Stem Cell-derived Exosomes and Fractional CO2 Laser for Acne Scars: A 12-week Prospective, Double-blind, Randomized, Split-face Study. Acta Derm Venereol. 2020 Nov 4;100(18):adv00310. doi: 10.2340/00015555-3666.

  PMID: 33073298 BACKGROUND

• Cho YB, Lee WY, Park KJ, Kim M, Yoo HW, Yu CS. Autologous adipose tissue-derived stem cells for the treatment of Crohn's fistula: a phase I clinical study. Cell Transplant. 2013;22(2):279-85. doi: 10.3727/096368912X656045. Epub 2012 Sep 21.

  PMID: 23006344 BACKGROUND

• Salloum RH, Rubin JP, Marra KG. The role of steroids in mesenchymal stem cell differentiation: molecular and clinical perspectives. Horm Mol Biol Clin Investig. 2013 Aug;14(1):3-14. doi: 10.1515/hmbci-2013-0016.

  PMID: 25436715 BACKGROUND

Study Officials

• Jonghee Lee, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 18, 2024
• Study Start: December 6, 2023
• Primary Completion: December 10, 2024
• Study Completion: March 28, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)