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

Atrophic Scar Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06210919
• Other study ID #: CIC101-01
• Status: Recruiting
• Phase: Phase 1
• Start date: December 6, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: January 2024
• Source: CellinCells
• Contact: HyeJung Park, Director
• Phone: +82-70-4469-9115
• Email: hjpark[@]cellincells.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3
• Est. completion date: October 31, 2024
• Est. primary completion date: July 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophic Scar
• Atrophy

Intervention

Biological:
• TRTP-101
Intradermal injection of the each of four sites

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
CellinCells

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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