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

Burn Degree Second Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05652816
• Other study ID #: KET-866/ETIK/2021
• Status: Recruiting
• Phase: Early Phase 1
• Start date: September 6, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2022
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Burn Degree Second
• Burn Degree Third
• Burns

Intervention

Procedure:
• Split-thickness skin graft
Transplantation of autologous skin to burn area

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

Locations

Country	Name	City	State
Indonesia	RSUPN Cipto Mangunkusumo	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Burn thickness	Thickness of burn evaluation using Rule of 9	Day of surgery
Primary	Burn thickness	Thickness of burn evaluation using Rule of 9	Day 7 after surgery
Primary	Burn thickness	Thickness of burn evaluation using Rule of 9	Day 14 after surgery
Primary	Burn thermography	Thermography evaluation using FLIRONE	Day of surgery
Primary	Burn thermography	Thermography evaluation using FLIRONE	Day 7 after surgery
Primary	Burn thermography	Thermography evaluation using FLIRONE	Day 14 after surgery
Primary	Systemic clinical evaluation	Mean arterial pressure measurement	Day of surgery
Primary	Systemic clinical evaluation	Mean arterial pressure measurement	Day 7 after surgery
Primary	Systemic clinical evaluation	Mean arterial pressure measurement	Day 14 after surgery
Primary	Systemic clinical evaluation	lactate measurement	Day of surgery
Primary	Systemic clinical evaluation	lactate measurement	Day 7 after surgery
Primary	Systemic clinical evaluation	lactate measurement	Day 14 after surgery
Primary	Systemic clinical evaluation	procalcitonin measurement	Day of surgery
Primary	Systemic clinical evaluation	procalcitonin measurement	Day 7 after surgery
Primary	Systemic clinical evaluation	procalcitonin measurement	Day 14 after surgery
Primary	Systemic clinical evaluation	urine excretion rate measurement	Day of surgery
Primary	Systemic clinical evaluation	urine excretion rate measurement	Day 7 after surgery
Primary	Systemic clinical evaluation	urine excretion rate measurement	Day 14 after surgery
Primary	Histoarchitecture evaluation	Haematoxylin & Eosin staining	Day of surgery
Primary	Histoarchitecture evaluation	Haematoxylin & Eosin staining	Day 14 after surgery
Primary	Histoarchitecture evaluation	Movat's Pentachrome staining	Day of surgery
Primary	Histoarchitecture evaluation	Movat's Pentachrome staining	Day 14 after surgery
Primary	Immunohistochemistry	collagen-1 labelling	Day of surgery
Primary	Immunohistochemistry	collagen-1 labelling	Day 14 after surgery
Primary	Immunohistochemistry	collagen-3 labelling	Day of surgery
Primary	Immunohistochemistry	collagen-3 labelling	Day 14 after surgery
Primary	Immunohistochemistry	von Willebrand labelling	Day of surgery
Primary	Immunohistochemistry	von Willebrand labelling	Day 14 after surgery
Primary	Immunohistochemistry	alpha-Smooth Muscle Actin labelling	Day of surgery
Primary	Immunohistochemistry	alpha-Smooth Muscle Actin labelling	Day 14 after surgery
Primary	Wound healing relative gene expression	TGFB1	Day of surgery
Primary	Wound healing relative gene expression	TGFB1	Day 14 after surgery
Primary	Wound healing relative gene expression	TGFB3	Day of surgery
Primary	Wound healing relative gene expression	TGFB3	Day 14 after surgery
Primary	Wound healing relative gene expression	Wnt4	Day of surgery
Primary	Wound healing relative gene expression	Wnt4	Day 14 after surgery
Primary	Wound healing relative gene expression	CTNNB1	Day of surgery
Primary	Wound healing relative gene expression	CTNNB1	Day 14 after surgery
Primary	Wound healing relative gene expression	MMP2	Day of surgery
Primary	Wound healing relative gene expression	MMP2	Day 14 after surgery
Primary	Wound healing relative gene expression	MMP9	Day of surgery
Primary	Wound healing relative gene expression	MMP9	Day 14 after surgery