RecruitingACTRN12622000619741

The efficacy of adipose-derived stem cells as treatment of hypertrophic scar: a non-randomized controlled trial

Sponsor

Theddeus O. H. Prasetyono

Enrollment

21 participants

Start Date

Aug 27, 2021

Study Type

Interventional

Conditions

Hypertrophic scar

Summary

This study aims to evaluate the effectivity of adipose-derived stem cells (ASCs) in alleviating hypertrophic scars. The subjects participating in this study will be divided into three groups: (1) those receiving ASCs injection; (2) those receiving ASC conditioned medium injection; (3) those receiving corticosteroid (triamcinolone acetonide 10 mg/mL) injection. It is expected that ASCs can alleviate hypertrophic scars in terms of symptoms, scar tissue structure, elasticity, color, and area in a similar or greater extent compared to ASC conditioned medium and corticosteroid (the current first line treatment of hypertrophic scar).

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 55 Yearss

Inclusion Criteria3

The subject has a hypertrophic scar which has persisted for at least 3 months after the initial wound healed
The hypertrophic scar is of an area of at least 1 x 1 cm2
The hypertrophic scar is at least 5-15 mm in thickness, confirmed with ultrasonography

Exclusion Criteria5

The scar is diagnosed as keloid
The subject has systemic conditions such as diabetes mellitus, hypertension, etc
The subject smoked or consumed alcohol within the last 6 months
The hypertrophic scar received corticosteroid injection therapy within the last month
Subjects have allergies to penicillin, streptomycin, and amphotericin

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Interventions

1. The first treatment group will be hypertrophic scars receiving injections of adipose-derived stem cells (ASCs) suspended in ASC conditioned medium. The suspended ASCs will be injected into hypertrophic scar with a dose of 1,000,000 cells in 1 ml of medium for a 1x1 cm2 area of hypertrophic scar. This trial will target 1x1 cm2 - 3x3 cm2 area of hypertrophic scar. Injection will be conducted three times, with 7-10-day interval between each injections. Injections will be done by a single doctor. 2. The second treatment group will be hypertrophic scars receiving injections of ASC conditioned medium without ASCs in it, with a dose of 1 ml of medium for a 1x1 cm2 area of hypertrophic scar. This trial will target 1x1 cm2 - 3x3 cm2 area of hypertrophic scar. Injection will be conducted three times, with 7-10-day interval between each injections. Injection will be performed by the same doctor as the doctor in the first treatment group. The volume of injections given will be recorded in a case report form and will be audited at the end of the study. The method of allocation used is consecutive allocation based on recruitment process following the order of: 7 subjects receiving ASC and 7 subjects receiving ASC conditioned medium.