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

CellinCells

Status and phase: Begins enrollment in 3 months; Phase 2; Phase 1

Conditions: Atrophic Scar

Treatments: Biological: TRTP-101; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07474467

CIC101-02

Details and patient eligibility

About

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.

Full description

A phase 1 clinical trial designed to evaluate dose-limiting toxicity (DLT) following single-dose administration of TRTP-101 into four or more atrophic scar sites.

Subsequently, a phase 2 clinical trial will be conducted using a placebo-controlled, split-face design to evaluate the safety and efficacy of TRTP-101. Eligible subjects will have atrophic scars approximately 2 cm in diameter located on both sides of the face (e.g., the cheek or temple areas), and TRTP-101 and placebo will be administered to the respective sides of the face.

Enrollment: 31 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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31 participants in 5 patient groups, including a placebo group

TRTP-101

Experimental group

Description:

High-dose TRTP-101

Treatment:

Biological: TRTP-101

TRPT-101 (Low dose group)

Experimental group

Description:

In a split-face design, low-dose TRTP-101 is administered to one side of the face and placebo to the contralateral side.

Treatment:

Biological: TRTP-101

Placebo (Low dose group)

Placebo Comparator group

Description:

In a split-face design, placebo is administered to one side of the face and low-dose TRTP-101 to the contralateral side.

Treatment:

Biological: Placebo

TRPT-101 (High dose group)

Experimental group

Description:

In a split-face design, high-dose TRTP-101 is administered to one side of the face and placebo to the contralateral side.

Treatment:

Biological: TRTP-101

Placebo (High dose group)

Placebo Comparator group

Description:

In a split-face design, placebo is administered to one side of the face and high-dose TRTP-101 to the contralateral side.

Treatment:

Biological: Placebo