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

Early Phase 1

Recruiting

• Conditions: Burn Degree Third; Burn Degree Second
• Interventions: Procedure: Split-thickness skin graft; Biological: Artificial skin graft; Biological: Artificial skin graft co-culture

• Registration Number: NCT05652816
• Lead Sponsor: Indonesia University

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

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 Timeline

• Study Start: 2022-09-06
• Study First Submitted: 2022-11-29
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-08
• Last Update Submitted: 2022-12-08
• Study First Posted: 2022-12-15
• Last Update Posted: 2022-12-15
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STSG (Split-Thickness Skin Graft)	Split-thickness skin graft	Patients treated with the standard treatment; autologous skin graft
Amnion Bilayer Only	Artificial skin graft	Patients treated with artificial graft only
Amnion Bilayer seeded with co-culture	Artificial skin graft co-culture	Patients treated with artificial graft seeded with autologous keratinocyte co-cultured with amnion epithelial stem cells

Primary Outcome Measures

Name	Time	Method
Burn thermography	Day 14 after surgery	Thermography evaluation using FLIRONE
Burn thickness	Day 14 after surgery	Thickness of burn evaluation using Rule of 9
Immunohistochemistry	Day 14 after surgery	alpha-Smooth Muscle Actin labelling
Systemic clinical evaluation	Day 14 after surgery	urine excretion rate measurement
Histoarchitecture evaluation	Day 14 after surgery	Movat's Pentachrome staining
Wound healing relative gene expression	Day 14 after surgery	MMP9

Trial Locations

Locations (1)

RSUPN Cipto Mangunkusumo; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia