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Burn Degree SecondEarly Phase 1NCT05652816

Biological Skin Graft With Keratinocyte-stem Cell Co-cultre for Burn Patients

A Early Phase 1 study testing Split-thickness skin graft, Artificial skin graft and Artificial skin graft co-culture in people with Burn Degree Second and Burn Degree Third, run by Universitas Indonesia at 1 site in Indonesia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this clinical trial is to test whether artificial skin graft can substitute autologous skin graft in current burn treatment. The main question it aims to answer is: Can artificial skin graft result in better wound healing compared to the current burn treatment; autologous skin graft? You will: Undergo… Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Burn Degree Second, Burn Degree Third
What is being tested?
Split-thickness skin graft, Artificial skin graft and Artificial skin graft co-culture
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteIndonesia
Study dates
6 Sep 2022to 31 Dec 2024
Phase
Early Phase 1
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 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Aged 18 - 55
  • Area of burn <50%
  • Acute phase burn (<120 hrs)
  • Have not undergo any surgery for burn treatment

Who cannot join

  • Immunocompromised
  • Have comorbidities

Trial locations and contacts

1 site in 1 country.

Indonesia1 site, 1 recruiting

  • RSUPN Cipto Mangunkusumo

    Jakarta Pusat, DKI Jakarta, 10430

    Aditya Wardhana, MD, +6287880021350, aditya_wrdn@yahoo.com

    Normalina Sandora, PhD, +6281298963425, normalina.sandora@gmail.com

    Recruiting

Other trials in Indonesia

About this study

Official title: Substitute Graft for Burns Using Biological Graft Seeded With Autologous Keratinocyte Co-cultured With Stem Cells

The goal of this clinical trial is to test whether artificial skin graft can substitute autologous skin graft in current burn treatment. The main question it aims to answer is:

  • Can artificial skin graft result in better wound healing compared to the current burn treatment; autologous skin graft?

You will:

  • Undergo debridement surgery
  • Receive artificial skin graft as an alternative to autologous skin graft
  • Undergo biopsy procedure of burn area

If there is a comparison group: Researchers will compare autologous skin graft group to see the wound healing process

Read the detailed description

Burn caused by working accidents occurs mostly in the male population of productive age (68.68%). Up to this date, the only treatment for grade 2B-3 burns patients in Indonesia is skin transplantation taken from their own body (autologous skin graft). This treatment has several drawbacks in which repeated surgery is sometimes necessary, the source of skin in patients with wide area of burn is limited, and patients that are in the elder age and have comorbidities have high mortality risk.

In order to find an alternative for autologous skin graft therapy, a combination of tissue engineering and stem cell therapy is used to invent an artificial skin graft. The present study attempts to evaluate the efficacy of artificial skin graft seeded with autologous keratinocyte and stem cells towards wound healing in burn patients. The artificial graft used in this study is amnion bilayer; a graft that was decellularized to remove donor's cells and then layered to form into 3-D.

To evaluate the efficacy, biopsies are taken from the burn area of patients to evaluate the histoarchitecture of patients' tissue by histological staining (H\&E and Movat's pentachrome, IHC collagen I, collagen III, vWF, and alpha-SMA) and measure the relative gene expression by qPCR. For clinical data, burn area calculation using Rule of 9 method and thermography measurement using FLIRONE. Furthermore, systemic evaluation of patients are done by monitoring the procalcitonin, lactate, mean arterial pressure, gradation of wound, and sensory of burn area. The evaluation and measurement mentioned above are then compared to patients treated with the current available therapy; autologous skin graft. The artificial skin graft is hoped to result in equal, if not better, wound healing in burn patients compared to autologous skin graft. The investigators hope that artificial skin graft can be an option, other than autologous skin graft, in treating burn patients in the future.

Being tested
Split-thickness skin graft, Artificial skin graft, Artificial skin graft co-culture
Keywords
artificial skin graft, keratinocyte, amnion epithelial stem cells, burn
Medical subject headings
Burns

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Split-thickness skin graftProcedure or surgery

    Transplantation of autologous skin to burn area

  • Artificial skin graftBiological

    Decellularized amnion membrane formed into 3-D matrix

  • Artificial skin graft co-cultureBiological

    Decellularized amnion membrane formed into 3-D matrix seeded with autologous keratinocyte co-cultured with amnion epithelial stem cells

Study groups in NCT05652816
Study groupRoleWhat they receive
STSG (Split-Thickness Skin Graft)Sham comparatorPatients treated with the standard treatment; autologous skin graft
Receives: Procedure: Split-thickness skin graft
Amnion Bilayer OnlyExperimentalPatients treated with artificial graft only
Receives: Biological: Artificial skin graft
Amnion Bilayer seeded with co-cultureExperimentalPatients treated with artificial graft seeded with autologous keratinocyte co-cultured with amnion epithelial stem cells
Receives: Biological: Artificial skin graft co-culture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Burn thickness

    Thickness of burn evaluation using Rule of 9

    Measured: Day of surgery

  2. Burn thickness

    Thickness of burn evaluation using Rule of 9

    Measured: Day 7 after surgery

  3. Burn thickness

    Thickness of burn evaluation using Rule of 9

    Measured: Day 14 after surgery

  4. Burn thermography

    Thermography evaluation using FLIRONE

    Measured: Day of surgery

  5. Burn thermography

    Thermography evaluation using FLIRONE

    Measured: Day 7 after surgery

  6. Burn thermography

    Thermography evaluation using FLIRONE

    Measured: Day 14 after surgery

  7. Systemic clinical evaluation

    Mean arterial pressure measurement

    Measured: Day of surgery

  8. Systemic clinical evaluation

    Mean arterial pressure measurement

    Measured: Day 7 after surgery

  9. Systemic clinical evaluation

    Mean arterial pressure measurement

    Measured: Day 14 after surgery

  10. Systemic clinical evaluation

    lactate measurement

    Measured: Day of surgery

  11. Systemic clinical evaluation

    lactate measurement

    Measured: Day 7 after surgery

  12. Systemic clinical evaluation

    lactate measurement

    Measured: Day 14 after surgery

  13. Systemic clinical evaluation

    procalcitonin measurement

    Measured: Day of surgery

  14. Systemic clinical evaluation

    procalcitonin measurement

    Measured: Day 7 after surgery

  15. Systemic clinical evaluation

    procalcitonin measurement

    Measured: Day 14 after surgery

  16. Systemic clinical evaluation

    urine excretion rate measurement

    Measured: Day of surgery

  17. Systemic clinical evaluation

    urine excretion rate measurement

    Measured: Day 7 after surgery

  18. Systemic clinical evaluation

    urine excretion rate measurement

    Measured: Day 14 after surgery

  19. Histoarchitecture evaluation

    Haematoxylin \& Eosin staining

    Measured: Day of surgery

  20. Histoarchitecture evaluation

    Haematoxylin \& Eosin staining

    Measured: Day 14 after surgery

  21. Histoarchitecture evaluation

    Movat's Pentachrome staining

    Measured: Day of surgery

  22. Histoarchitecture evaluation

    Movat's Pentachrome staining

    Measured: Day 14 after surgery

  23. Immunohistochemistry

    collagen-1 labelling

    Measured: Day of surgery

  24. Immunohistochemistry

    collagen-1 labelling

    Measured: Day 14 after surgery

  25. Immunohistochemistry

    collagen-3 labelling

    Measured: Day of surgery

  26. Immunohistochemistry

    collagen-3 labelling

    Measured: Day 14 after surgery

  27. Immunohistochemistry

    von Willebrand labelling

    Measured: Day of surgery

  28. Immunohistochemistry

    von Willebrand labelling

    Measured: Day 14 after surgery

  29. Immunohistochemistry

    alpha-Smooth Muscle Actin labelling

    Measured: Day of surgery

  30. Immunohistochemistry

    alpha-Smooth Muscle Actin labelling

    Measured: Day 14 after surgery

  31. Wound healing relative gene expression

    TGFB1

    Measured: Day of surgery

  32. Wound healing relative gene expression

    TGFB1

    Measured: Day 14 after surgery

  33. Wound healing relative gene expression

    TGFB3

    Measured: Day of surgery

  34. Wound healing relative gene expression

    TGFB3

    Measured: Day 14 after surgery

  35. Wound healing relative gene expression

    Wnt4

    Measured: Day of surgery

  36. Wound healing relative gene expression

    Wnt4

    Measured: Day 14 after surgery

  37. Wound healing relative gene expression

    CTNNB1

    Measured: Day of surgery

  38. Wound healing relative gene expression

    CTNNB1

    Measured: Day 14 after surgery

  39. Wound healing relative gene expression

    MMP2

    Measured: Day of surgery

  40. Wound healing relative gene expression

    MMP2

    Measured: Day 14 after surgery

  41. Wound healing relative gene expression

    MMP9

    Measured: Day of surgery

  42. Wound healing relative gene expression

    MMP9

    Measured: Day 14 after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2022
  2. Study start6 Sep 2022
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05652816
Sponsor's protocol ID
KET-866/ETIK/2021
Status last verified
Dec 2022
First submitted
29 Nov 2022
Last updated
15 Dec 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Split-thickness skin graft, Artificial skin graft and Artificial skin graft co-culture in people with Burn Degree Second and Burn Degree Third, run by Universitas Indonesia at 1 site in Indonesia.

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 4 inclusion and 2 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 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Burn thickness (time frame: Day of surgery). The study lists 42 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 NCT05652816.

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 15 Dec 2022.

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