Clincosm LogoSign in Get a demo

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

Sponsor
Indonesia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05652816
Collaborator
(none)
20
Enrollment
1
Location
3
Arms
27.8
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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 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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Split-thickness skin graft
  • Biological: Artificial skin graft
  • Biological: Artificial skin graft co-culture
 Early Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Substitute Graft for Burns Using Biological Graft Seeded With Autologous Keratinocyte Co-cultured With Stem Cells
Actual Study Start Date :
Sep 6, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Sham Comparator: STSG (Split-Thickness Skin Graft)

Patients treated with the standard treatment; autologous skin graft

Procedure: Split-thickness skin graft
Transplantation of autologous skin to burn area
Experimental: Amnion Bilayer Only

Patients treated with artificial graft only

Biological: Artificial skin graft
Decellularized amnion membrane formed into 3-D matrix
Experimental: Amnion Bilayer seeded with co-culture

Patients treated with artificial graft seeded with autologous keratinocyte co-cultured with amnion epithelial stem cells

Biological: Artificial skin graft co-culture
Decellularized amnion membrane formed into 3-D matrix seeded with autologous keratinocyte co-cultured with amnion epithelial stem cells

Outcome Measures

Primary Outcome Measures

  1. Burn thickness [Day of surgery]

    Thickness of burn evaluation using Rule of 9

  2. Burn thickness [Day 7 after surgery]

    Thickness of burn evaluation using Rule of 9

  3. Burn thickness [Day 14 after surgery]

    Thickness of burn evaluation using Rule of 9

  4. Burn thermography [Day of surgery]

    Thermography evaluation using FLIRONE

  5. Burn thermography [Day 7 after surgery]

    Thermography evaluation using FLIRONE

  6. Burn thermography [Day 14 after surgery]

    Thermography evaluation using FLIRONE

  7. Systemic clinical evaluation [Day of surgery]

    Mean arterial pressure measurement

  8. Systemic clinical evaluation [Day 7 after surgery]

    Mean arterial pressure measurement

  9. Systemic clinical evaluation [Day 14 after surgery]

    Mean arterial pressure measurement

  10. Systemic clinical evaluation [Day of surgery]

    lactate measurement

  11. Systemic clinical evaluation [Day 7 after surgery]

    lactate measurement

  12. Systemic clinical evaluation [Day 14 after surgery]

    lactate measurement

  13. Systemic clinical evaluation [Day of surgery]

    procalcitonin measurement

  14. Systemic clinical evaluation [Day 7 after surgery]

    procalcitonin measurement

  15. Systemic clinical evaluation [Day 14 after surgery]

    procalcitonin measurement

  16. Systemic clinical evaluation [Day of surgery]

    urine excretion rate measurement

  17. Systemic clinical evaluation [Day 7 after surgery]

    urine excretion rate measurement

  18. Systemic clinical evaluation [Day 14 after surgery]

    urine excretion rate measurement

  19. Histoarchitecture evaluation [Day of surgery]

    Haematoxylin & Eosin staining

  20. Histoarchitecture evaluation [Day 14 after surgery]

    Haematoxylin & Eosin staining

  21. Histoarchitecture evaluation [Day of surgery]

    Movat's Pentachrome staining

  22. Histoarchitecture evaluation [Day 14 after surgery]

    Movat's Pentachrome staining

  23. Immunohistochemistry [Day of surgery]

    collagen-1 labelling

  24. Immunohistochemistry [Day 14 after surgery]

    collagen-1 labelling

  25. Immunohistochemistry [Day of surgery]

    collagen-3 labelling

  26. Immunohistochemistry [Day 14 after surgery]

    collagen-3 labelling

  27. Immunohistochemistry [Day of surgery]

    von Willebrand labelling

  28. Immunohistochemistry [Day 14 after surgery]

    von Willebrand labelling

  29. Immunohistochemistry [Day of surgery]

    alpha-Smooth Muscle Actin labelling

  30. Immunohistochemistry [Day 14 after surgery]

    alpha-Smooth Muscle Actin labelling

  31. Wound healing relative gene expression [Day of surgery]

    TGFB1

  32. Wound healing relative gene expression [Day 14 after surgery]

    TGFB1

  33. Wound healing relative gene expression [Day of surgery]

    TGFB3

  34. Wound healing relative gene expression [Day 14 after surgery]

    TGFB3

  35. Wound healing relative gene expression [Day of surgery]

    Wnt4

  36. Wound healing relative gene expression [Day 14 after surgery]

    Wnt4

  37. Wound healing relative gene expression [Day of surgery]

    CTNNB1

  38. Wound healing relative gene expression [Day 14 after surgery]

    CTNNB1

  39. Wound healing relative gene expression [Day of surgery]

    MMP2

  40. Wound healing relative gene expression [Day 14 after surgery]

    MMP2

  41. Wound healing relative gene expression [Day of surgery]

    MMP9

  42. Wound healing relative gene expression [Day 14 after surgery]

    MMP9

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Aged 18 - 55

  • Area of burn <50%

  • Acute phase burn (<120 hrs)

  • Have not undergo any surgery for burn treatment

Exclusion Criteria:

  • Immunocompromised

  • Have comorbidities

Contacts and Locations

Locations

Site City State Country Postal Code
1 RSUPN Cipto Mangunkusumo Jakarta Pusat DKI Jakarta Indonesia 10430

Sponsors and Collaborators

  • Indonesia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
dr. Aditya Wardhana, Head of Burns Unit, Cipto Mangunkusumo National Hospital, Indonesia University
ClinicalTrials.gov Identifier:
NCT05652816
Other Study ID Numbers:
  • KET-866/ETIK/2021
First Posted:
Dec 15, 2022
Last Update Posted:
Dec 15, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by dr. Aditya Wardhana, Head of Burns Unit, Cipto Mangunkusumo National Hospital, Indonesia University
artificial skin graft
keratinocyte
amnion epithelial stem cells
burn
Additional relevant MeSH terms:
Burns

Study Results

No Results Posted as of Dec 15, 2022