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

Plain Language Summary

Simplified for easier understanding

Hypertrophic scars are raised, firm, often itchy or painful scars that develop after an injury or surgery. Unlike keloid scars, they stay within the original wound boundary but can still significantly affect appearance and wellbeing. The standard treatment is injections of a corticosteroid (triamcinolone), which can flatten and soften the scar over time, but results vary. This study tests whether injecting the scar with adipose-derived stem cells (stem cells harvested from fatty tissue) or with a conditioned medium produced by those stem cells (essentially the biological signals they secrete) can be as effective as — or better than — standard steroid injections. All three treatments are being compared side by side in terms of scar thickness, elasticity, colour, and symptom relief. You may be eligible if you are between 18 and 55 years old, have a hypertrophic scar that has persisted for at least 3 months after healing, the scar is at least 1 x 1 cm in area and 5–15 mm thick on ultrasound. People with keloid scars (which extend beyond the original wound), systemic conditions like diabetes or hypertension, smoking or alcohol use in the past 6 months, or previous steroid injections in the last month are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.