+1 (202) 780-3397Study on wound healing after cutaneous lesion and reconstructed autologous pigmented skin dressing (APSD) in nude mice: GLP-study
Joint Event on 2nd Global Summit on Dermatology and Cosmetology & 3rd International Conference on Wound Care, Tissue Repair and Regenerative Medicine
September 09-10, 2019 | Edinburgh, Scotland
Jean Christophe Lepivert, E Desnouveaux, V Casoli and M Cario
University of Bordeaux, France University Hospital of Bordeaux, France
Posters & Accepted Abstracts : Dermatol Res Skin Care
Abstract:
Authors develop a process of in vitro skin reconstruction from
locally anesthetised patient’s biopsies. This process is oriented
though applications with patient presenting cutaneous
defect as chronical wounds, burn injuries or congenital
melanocytic nevus. One step of this development process
is reconstructed skin production under Good Laboratory
Practices (GLP). Subsequently, application of Autologous
Pigmented Skin Dressing (APSD) on immunodeficient mouse
model, demonstrates its harmlessness and functionality
with required sanitary characteristics. Clinical results will be
presented in this paper.
Materials and methods: This technology consists in
reconstructing autologous pigmented skin on a collagen
matrix such as IntegraTM or Matriderm®. Skin from breast
reductions was taken from the operating room and managed
to the French Blood Establishment (FBE). Keratinocytes,
Melanocytes and fibroblasts were extract from the
biopsy harvested on patient himself and cultured for cells
amplifications. On top of the collagen matrix, fibroblasts were
seeded to remodel collagen and after this step, keratinocytes
and melanocytes were seeded to produce the epidermal
layer. APSD were produced in 3-5 weeks. The APSD (Test Item
approximately 6 cm2) and its culture media was provided by
truck at 18-20°C to testing facility (about 500 km). Testing
facility stored under a 37°C, 5% CO2 humidified atmosphere
for up to 24 hours. From the Operating room to mice
coverage, skin, cells and reconstructed skin were identified
and traceable. From July 2018 to July 2019, 4 groups of 7 mice
were implanted. For each group, 6 mice were treated with
test item and one or two mice with collagen matrix alone as
control. Under general anesthesia defects (3x2 cm) on dorsum
of mice was done and covered with APSD or collagen matrix
alone. This study was conducted according to GLP and EMEA
EMEA/CHMP/410869/2006 31/07/2007) guideline. Wound
healing, clinical behavior, any symptom, tumor development,
and mortality sign were notice every day. Weight, food and
water consumption were notice every week.
Results: 1 mouse did not survive to surgery. Groups 1, 3 and
4 healed well. Follow up demonstrated, a good integration
of APSD with minor retraction and a diffuse pigmentation.
Group 2 healed with multiples milimetric wounds, and during
the healing process, skin retraction appeared which increased
with weeks. All collagen matrixes (control group) didn’t heal
and made complete skin retraction for skin closure. Except
one mice which had a nice APSD but loss of weight leading
to sacrificed, the other mice grew up, drank and ate normally
Discussion: Bioengineered APSD demonstrated enthusiastic
results regarding wound healing. Reconstructed skin could
be easily handled and shipped far from the reconstructed
area. APSD were simply immerged in cultured medium. APSD
groups healed well except for one batch for which the quality
of cells seeded was bad leading to thin APSD.
Conclusion: Next step will be the clinical trail. The first
selected patients, which will be treated with the autologouspigmented
skin dressing, could have chronic wounds that
could not be close with traditional treatment as patients with
bad general condition. Phase 1 could be done in 2020 and
time to market calculated for 2025.
Biography:
Jean Christophe Lepivert is currently working as a consultant in University Hospital of Bordeaux, Bordeaux, France. He is also the head of burn surgery unit. His research interest lies in plastic, reconstructive and aesthetic surgery, burns, etc., He also has various research publications in the international journals.
E-mail: jc.lepivert@gmail.com
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