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

Phase 1

Active, not recruiting

• Conditions: Atrophic Scar
• Interventions: Biological: TRTP-101

• Registration Number: NCT06210919
• Lead Sponsor: CellinCells

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.

Detailed 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.

Study Timeline

• Study Start: 2023-12-06
• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-08
• Study First Posted: 2024-01-18
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-05
• Last Update Posted: 2024-10-09
• Primary Completion: 2024-11-22
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TRTP-101	TRTP-101	Micro-Block (MiB) manufactured from autologous Adipose-derived Mesenchymal Stem Cells

Primary Outcome Measures

Name	Time	Method
Number of Participants with Dose Limiting Toxicity	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 Outcome Measures

Name	Time	Method
Mean percent change in atrophic scar volume	1, 4, 8 and 12 weeks	The depressed volume of atropic scar is measured at baseline and post-treatment visits

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of