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

NCT ID: NCT05004779

Last Updated: 2021-08-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-10
• Study Completion Date: 2022-04-20

Brief Summary

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

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.

Conditions

Stem Cell Media; Hypertrophic Scar; Regeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

human stem cell media apply lesion

human media apply after non ablative laser treatment

Group Type: EXPERIMENTAL

human stem cell conditioned media was applied after non-ablative laser therapy

Intervention Type: PROCEDURE

After laser treatment on hypertrophic scars, human stem cell media was applied to one side

control condition lesion

normal saline apply after non ablative laser treatment

Group Type: SHAM_COMPARATOR

normal saline was applied after non ablative laser therapy

Intervention Type: PROCEDURE

physiological saline was applied to the other side.

Interventions

human stem cell conditioned media was applied after non-ablative laser therapy

After laser treatment on hypertrophic scars, human stem cell media was applied to one side

Intervention Type: PROCEDURE

normal saline was applied after non ablative laser therapy

physiological saline was applied to the other side.

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Research Foundation of Korea

OTHER

Sponsor Role: collaborator

Hangang Sacred Heart Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Cheong Hoon Seo, M.D.

Role: CONTACT

chseomd@gmail.com

+82 2 2639 5738

References

Onur Erol O, Agaoglu G, Jawad MA. Combined Non-Ablative Laser and Microfat Grafting for Burn Scar Treatment. Aesthet Surg J. 2019 Mar 14;39(4):NP55-NP67. doi: 10.1093/asj/sjy291.

Reference Type: BACKGROUND

PMID: 30403775 (View on PubMed)

Jayaraman P, Nathan P, Vasanthan P, Musa S, Govindasamy V. Stem cells conditioned medium: a new approach to skin wound healing management. Cell Biol Int. 2013 Oct;37(10):1122-8. doi: 10.1002/cbin.10138. Epub 2013 Jun 24.

Reference Type: RESULT

PMID: 23716460 (View on PubMed)

Park IS. Enhancement of Wound Healing by Conditioned Medium of Adipose-Derived Stromal Cell with Photobiomodulation in Skin Wound. Int J Stem Cells. 2021 May 30;14(2):212-220. doi: 10.15283/ijsc20175.

Reference Type: RESULT

PMID: 33632992 (View on PubMed)

Other Identifiers

HangangSHH-13

Identifier Type: -

Identifier Source: org_study_id