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

University of Indonesia (UI)

Status and phase: Enrolling; Early Phase 1

Conditions: Burn Degree Third; Burn Degree Second

Treatments: Biological: Artificial skin graft co-culture; Biological: Artificial skin graft; Procedure: Split-thickness skin graft

Study type: Interventional

Funder types: Other

Identifiers

NCT05652816

KET-866/ETIK/2021

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

STSG (Split-Thickness Skin Graft)

Sham Comparator group

Description:

Patients treated with the standard treatment; autologous skin graft

Treatment:

Procedure: Split-thickness skin graft

Amnion Bilayer Only

Experimental group

Description:

Patients treated with artificial graft only

Treatment:

Biological: Artificial skin graft

Amnion Bilayer seeded with co-culture

Experimental group

Description:

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

Treatment:

Biological: Artificial skin graft co-culture