Regenerative Effects of Human Stem Cell Media After Laser Therapy in Hypertrophic Scar

Study Overview
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Brief Summary
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The purpose of this study was to determine the effect of combined treatment using nonablative laser and human stem cell media (HSCM) on the regeneration of hypertrophic scars that occurred after burns.

Detailed Description
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The purpose of this study was to determine the effect of combined treatment using nonablative laser and human stem cell media (HSCM) on the regeneration of hypertrophic scars that occurred after burns. Nonablative laser treatment was performed on 30 patients with hypertrophic scars on both sides of the same part of the body. Immediately after the laser treatment, the hypertrophic scars of right side to which HSCM was applied and the left side with the same body position were defined as a control scar, and normal saline was applied. Over the next 6 days, HSCM and moisturizer were applied on the scars of right side, and only moisturizer was applied on the control scar of left side. Laser treatment was performed three times on the hypertrophic scar at 4 weeks intervals. The skin test on hypertrophic scar was evaluated before laser treatment and re-evaluated on the 7the day after the 3rd laser treatment. The thickness was measured with a ultrasonic wave equipment (128 BW1 Medison, Korea). Mexameter® (MX18, Courage-Khazaka Electronics GmbH, Germany) was used to measure melanin levels and the severity of erythema. The higher values indicating a darker and redder skin. Transepidermal water loss (TEWL) was measured with a Tewameter® (Courage-Khazaka Electronic GmbH, Germany), which is used for evaluating water evaporation. Sebum in the scars was measured with the Sebumeter® (Courage-Khazaka Electronic GmbH, Germany). The measurement is based on the principle of grease-spot photometry using a cassette with its special tape. A microprocessor calculates the result, which is shown on the display in μg/cm2. Elasticity was measured using Cutometer SEM 580® (Courage-Khazaka Electronic GmbH, Cologne, Germany), which applies negative pressure (450 mbar) on the skin. The numeric values (mm) of the skin's distortion is presented as the elasticity (Table 1). Two seconds of negative pressure of 450 mbar is followed by 2 s of recess, and this consists of a complete cycle. Three measurement cycles were conducted, and the average values were obtained. To evaluate the effect of HSCM, investigators compared the skin test results (thickness, melanin, erythema, TEWL, sebum, and skin elasticity levels) between the right side and control side, from baseline measures immediately before the laser treatment and measures on the 7the day after the 3rd laser treatment. Outcome measurements and data analyses were performed by a trained and blinded outcome assessor who was not involved in the intervention. Possible complications (pain, ecchymosis, skin abrasion, and swelling) were observed.

Official Title
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Regenerative Effects of Human Stem Cell Media After Laser Therapy in Hypertrophic Scar Caused by Burns

Conditions
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Stem Cell Media, Hypertrophic Scar, Regeneration

Intervention / Treatment
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* Procedure: human stem cell conditioned media was applied after non-ablative laser therapy
* Procedure: normal saline was applied after non ablative laser therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: partial or full-thickness burns that healed spontaneously or required skin grafting with hypertrophic scars on the right and left sides of the same body part Exclusion Criteria: Patients with open wounds or infection on the burn scars those taking steroids for the scars with allergies to topical anesthetic cream those who were pregnant undergoing any other medical treatment or condition affecting wound healing (e.g., diabetes)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: After laser treatment on hypertrophic scars, human stem cell conditioned media was applied to one side and physiological saline was applied to the other side.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: human stem cell media apply lesion<br>human media apply after non ablative laser treatment | Procedure: human stem cell conditioned media was applied after non-ablative laser therapy<br>* After laser treatment on hypertrophic scars, human stem cell media was applied to one side<br>|
| Sham Comparator: control condition lesion<br>normal saline apply after non ablative laser treatment | Procedure: normal saline was applied after non ablative laser therapy<br>* physiological saline was applied to the other side.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| scar thickness (cm) | The thickness was measured with a ultrasonic wave equipment | baseline | 
| change from baseline scar thickness at 3 months (cm) | the change of scar thickness was measured with a ultrasonic wave equipment | after 3 months intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| melanin levels (arbitraty units; AU) | the higher values indicating a darker | baseline | 
| change from baseline melanin level at 3 months (arbitraty units; AU) | the higher values indicating a darker | after 3 months intervention | 
| erythema level (arbitraty units; AU) | the higher values indicating a redder skin | baseline | 
| change from baseline erythema level at 3 months (arbitraty units; AU) | the higher values indicating a redder skin | after 3 months intervention | 
| transepidermal water loss (g/h/m2) | the higher the number, the more dry the skin is. | baseline | 
| change from baseline transepidermal water loss at 3 months (g/h/m2) | the higher the number, the more dry the skin is. | after 3 months intervention | 
| Sebum level (μg sebum/cm2) | A microprocessor calculates the result, which is shown on the display in μg/cm2. The higher the number, the more oily the skin is. | baseline | 
| change from baseline sebum level at 3 months (μg sebum/cm2) | A microprocessor calculates the result, which is shown on the display in μg/cm2. The higher the number, the more oily the skin is. | after 3 months intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stem cell media, non ablative laser, hypertrophic scar, burns, regeneration