Stem Cell MediaNCT05004779
Regenerative Effects of Human Stem Cell Media After Laser Therapy in Hypertrophic Scar
A study testing human stem cell conditioned media was applied after non-ablative laser therapy and normal saline was applied after non ablative laser therapy in people with Stem Cell Media and Hypertrophic Scar, run by Hangang Sacred Heart Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Stem Cell Media, Hypertrophic Scar, Regeneration
- What is being tested?
- human stem cell conditioned media was applied after non-ablative laser therapy and normal saline was applied after non ablative laser therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2021to 20 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Regenerative Effects of Human Stem Cell Media After Laser Therapy in Hypertrophic Scar Caused by Burns
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.
Read the 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
- Being tested
- human stem cell conditioned media was applied after non-ablative laser therapy, normal saline was applied after non ablative laser therapy
- Keywords
- stem cell media, non ablative laser, hypertrophic scar, burns, regeneration
- Medical subject headings
- Cicatrix, Hypertrophic, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human stem cell conditioned media was applied after non-ablative laser therapyProcedure or surgery
After laser treatment on hypertrophic scars, human stem cell media was applied to one side
normal saline was applied after non ablative laser therapyProcedure or surgery
physiological saline was applied to the other side.
| Study group | Role | What they receive |
|---|---|---|
| human stem cell media apply lesion | Experimental | human media apply after non ablative laser treatment Receives: Procedure: human stem cell conditioned media was applied after non-ablative laser therapy |
| control condition lesion | Sham comparator | normal saline apply after non ablative laser treatment Receives: Procedure: normal saline was applied after non ablative laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
scar thickness (cm)
The thickness was measured with a ultrasonic wave equipment
Measured: baseline
change from baseline scar thickness at 3 months (cm)
the change of scar thickness was measured with a ultrasonic wave equipment
Measured: after 3 months intervention
Secondary outcomes (8)
melanin levels (arbitraty units; AU)
the higher values indicating a darker
Measured: baseline
change from baseline melanin level at 3 months (arbitraty units; AU)
the higher values indicating a darker
Measured: after 3 months intervention
erythema level (arbitraty units; AU)
the higher values indicating a redder skin
Measured: baseline
change from baseline erythema level at 3 months (arbitraty units; AU)
the higher values indicating a redder skin
Measured: after 3 months intervention
transepidermal water loss (g/h/m2)
the higher the number, the more dry the skin is.
Measured: baseline
change from baseline transepidermal water loss at 3 months (g/h/m2)
the higher the number, the more dry the skin is.
Measured: 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.
Measured: 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.
Measured: after 3 months intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start10 Aug 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion20 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stem Cell MediaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- 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 blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangang Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004779
- Sponsor's protocol ID
- HangangSHH-13
- Status last verified
- Jul 2021
- First submitted
- 29 Jul 2021
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30403775Jayaraman 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.
PubMed 23716460Park 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.
PubMed 33632992
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regenerative Effects of Human Stem Cell Media After Laser Therapy in Hypertrophic Scar Caused by Burns
- ClinicalTrials.gov ID
- NCT05004779
- Acronym / sponsor ID
- HangangSHH-13
- Conditions
- Stem Cell Media, Hypertrophic Scar, Regeneration
- Keywords
- stem cell media, non ablative laser, hypertrophic scar, burns, regeneration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hangang Sacred Heart HospitalUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea
- Study start
- 10 Aug 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 20 Apr 2022 (estimated)
- First posted
- 13 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| human stem cell media apply lesion | Experimental | Procedure: human stem cell conditioned media was applied after non-ablative laser therapyhuman media apply after non ablative laser treatment |
| control condition lesion | Sham comparator | Procedure: normal saline was applied after non ablative laser therapynormal saline apply after non ablative laser treatment |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| human stem cell conditioned media was applied after non-ablative laser therapyAfter laser treatment on hypertrophic scars, human stem cell media was applied to one side | Procedure or surgery | human stem cell media apply lesion |
| normal saline was applied after non ablative laser therapyphysiological saline was applied to the other side. | Procedure or surgery | control condition lesion |
Primary outcome
scar thickness (cm)
Time frame: baseline
The thickness was measured with a ultrasonic wave equipment
change from baseline scar thickness at 3 months (cm)
Time frame: after 3 months intervention
the change of scar thickness was measured with a ultrasonic wave equipment
8 secondary outcomes
melanin levels (arbitraty units; AU)
Time frame: baseline
change from baseline melanin level at 3 months (arbitraty units; AU)
Time frame: after 3 months intervention
erythema level (arbitraty units; AU)
Time frame: baseline
change from baseline erythema level at 3 months (arbitraty units; AU)
Time frame: after 3 months intervention
transepidermal water loss (g/h/m2)
Time frame: baseline
change from baseline transepidermal water loss at 3 months (g/h/m2)
Time frame: after 3 months intervention
Sebum level (μg sebum/cm2)
Time frame: baseline
change from baseline sebum level at 3 months (μg sebum/cm2)
Time frame: after 3 months intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Background: PubMed 30403775Onur 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 publication: PubMed 23716460Jayaraman 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 publication: PubMed 33632992Park 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing human stem cell conditioned media was applied after non-ablative laser therapy and normal saline was applied after non ablative laser therapy in people with Stem Cell Media and Hypertrophic Scar, run by Hangang Sacred Heart Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheong Hoon Seo, M.D. (+82 2 2639 5738, chseomd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
scar thickness (cm) (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05004779, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2021.