Journal Article

Bioengineering a Human Plasma‐Based Epidermal Substitute With Efficient Grafting Capacity and High Content in Clonogenic Cells

Nivet, Muriel, Alexaline, Maia M., Trouillas, Marina, Bourreau, Emilie, Doucet, Christelle, Leclerc, Thomas, Duhamel, Patrick, Martin, Michele T., Lataillade, Jean-Jacques, Fortunel, Nicolas O.

2015

Overview

This study developed a human plasma‐based epidermal substitute (hPBES) as an alternative to traditional cultured epithelial autografts for epidermal coverage in cases of massive burn, and critical quality controls were put in place for preclinical and clinical studies. This work highlights the importance of integrating relevant multiparameter quality controls into the bioengineering of new skin substitutes before they reach clinical development. Cultured epithelial autografts (CEAs) produced from a small, healthy skin biopsy represent a lifesaving surgical technique in cases of full‐thickness skin burn covering >50% of total body surface area. CEAs also present numerous drawbacks, among them the use of animal proteins and cells, the high fragility of keratinocyte sheets, and the immaturity of the dermal‐epidermal junction, leading to heavy cosmetic and functional sequelae. To overcome these weaknesses, we developed a human plasma‐based epidermal substitute (hPBES) for epidermal coverage in cases of massive burn, as an alternative to traditional CEA, and set up critical quality controls for preclinical and clinical studies. In this study, phenotypical analyses in conjunction with functional assays (clonal analysis, long‐term culture, or in vivo graft) showed that our new substitute fulfills the biological requirements for epidermal regeneration. hPBES keratinocytes showed high potential for cell proliferation and subsequent differentiation similar to healthy skin compared with a well‐known reference material, as ascertained by a combination of quality controls. This work highlights the importance of integrating relevant multiparameter quality controls into the bioengineering of new skin substitutes before they reach clinical development. Significance This work involves the development of a new bioengineered epidermal substitute with pertinent functional quality controls. The novelty of this work is based on this quality approach.

• Publisher: AlphaMed Press,Oxford University Press
• Subject: Administrative support / Animals / Artificial / Autografts / Bioengineering / Burn treatment / Burns / Burns - metabolism / Burns - pathology / Burns - therapy / Cell Proliferation / Data analysis / Dermis - metabolism / Dermis - pathology / Efficiency / Epidermis - metabolism / Epidermis - pathology / Female / Fibrin / Health care / Heterografts / Humans / Keratinocytes / Keratinocytes - metabolism / Keratinocytes - pathology / Keratinocytes - transplantation / Mice / Mice, Inbred NOD / Mice, SCID / Plasma / Proteins / Quality Control / Quality standards / Skin / Skin, Artificial / Tissue Engineering / Tissue Engineering and Regenerative Medicine