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

Primary Purpose

Stem Cell Media, Hypertrophic Scar, Regeneration

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
human stem cell conditioned media was applied after non-ablative laser therapy
normal saline was applied after non ablative laser therapy
Sponsored by
Hangang Sacred Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stem Cell Media focused on measuring stem cell media, non ablative laser, hypertrophic scar, burns, regeneration

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    human stem cell media apply lesion

    control condition lesion

    Arm Description

    human media apply after non ablative laser treatment

    normal saline apply after non ablative laser treatment

    Outcomes

    Primary Outcome Measures

    scar thickness (cm)
    The thickness was measured with a ultrasonic wave equipment
    change from baseline scar thickness at 3 months (cm)
    the change of scar thickness was measured with a ultrasonic wave equipment

    Secondary Outcome Measures

    melanin levels (arbitraty units; AU)
    the higher values indicating a darker
    change from baseline melanin level at 3 months (arbitraty units; AU)
    the higher values indicating a darker
    erythema level (arbitraty units; AU)
    the higher values indicating a redder skin
    change from baseline erythema level at 3 months (arbitraty units; AU)
    the higher values indicating a redder skin
    transepidermal water loss (g/h/m2)
    the higher the number, the more dry the skin is.
    change from baseline transepidermal water loss at 3 months (g/h/m2)
    the higher the number, the more dry the skin is.
    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.
    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.

    Full Information

    First Posted
    July 29, 2021
    Last Updated
    August 9, 2021
    Sponsor
    Hangang Sacred Heart Hospital
    Collaborators
    National Research Foundation of Korea
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05004779
    Brief Title
    Regenerative Effects of Human Stem Cell Media After Laser Therapy in Hypertrophic Scar
    Official Title
    Regenerative Effects of Human Stem Cell Media After Laser Therapy in Hypertrophic Scar Caused by Burns
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 10, 2021 (Anticipated)
    Primary Completion Date
    December 31, 2021 (Anticipated)
    Study Completion Date
    April 20, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hangang Sacred Heart Hospital
    Collaborators
    National Research Foundation of Korea

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stem Cell Media, Hypertrophic Scar, Regeneration
    Keywords
    stem cell media, non ablative laser, hypertrophic scar, burns, regeneration

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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
    Participant
    Masking Description
    After laser treatment on hypertrophic scars, human stem cell media was applied to one side and physiological saline was applied to the other side.
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    human stem cell media apply lesion
    Arm Type
    Experimental
    Arm Description
    human media apply after non ablative laser treatment
    Arm Title
    control condition lesion
    Arm Type
    Sham Comparator
    Arm Description
    normal saline apply after non ablative laser treatment
    Intervention Type
    Procedure
    Intervention Name(s)
    human stem cell conditioned media was applied after non-ablative laser therapy
    Intervention Description
    After laser treatment on hypertrophic scars, human stem cell media was applied to one side
    Intervention Type
    Procedure
    Intervention Name(s)
    normal saline was applied after non ablative laser therapy
    Intervention Description
    physiological saline was applied to the other side.
    Primary Outcome Measure Information:
    Title
    scar thickness (cm)
    Description
    The thickness was measured with a ultrasonic wave equipment
    Time Frame
    baseline
    Title
    change from baseline scar thickness at 3 months (cm)
    Description
    the change of scar thickness was measured with a ultrasonic wave equipment
    Time Frame
    after 3 months intervention
    Secondary Outcome Measure Information:
    Title
    melanin levels (arbitraty units; AU)
    Description
    the higher values indicating a darker
    Time Frame
    baseline
    Title
    change from baseline melanin level at 3 months (arbitraty units; AU)
    Description
    the higher values indicating a darker
    Time Frame
    after 3 months intervention
    Title
    erythema level (arbitraty units; AU)
    Description
    the higher values indicating a redder skin
    Time Frame
    baseline
    Title
    change from baseline erythema level at 3 months (arbitraty units; AU)
    Description
    the higher values indicating a redder skin
    Time Frame
    after 3 months intervention
    Title
    transepidermal water loss (g/h/m2)
    Description
    the higher the number, the more dry the skin is.
    Time Frame
    baseline
    Title
    change from baseline transepidermal water loss at 3 months (g/h/m2)
    Description
    the higher the number, the more dry the skin is.
    Time Frame
    after 3 months intervention
    Title
    Sebum level (μg sebum/cm2)
    Description
    A microprocessor calculates the result, which is shown on the display in μg/cm2. The higher the number, the more oily the skin is.
    Time Frame
    baseline
    Title
    change from baseline sebum level at 3 months (μg sebum/cm2)
    Description
    A microprocessor calculates the result, which is shown on the display in μg/cm2. The higher the number, the more oily the skin is.
    Time Frame
    after 3 months intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cheong Hoon Seo, M.D.
    Phone
    +82 2 2639 5738
    Email
    chseomd@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30403775
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23716460
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    33632992
    Citation
    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.
    Results Reference
    result

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

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