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

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Status and phase: Enrolling; Phase 1

Conditions: Atrophic Scar

Treatments: Biological: TRTP-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT06210919

CIC101-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

TRTP-101

Experimental group

Description:

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

Treatment:

Biological: TRTP-101