The results of the use of these biosynthetic scaffolds open the door to a clinical trial at the end of the year.
Researchers from the Regeneration and Transplant Group of the Health Research Institute of La Fe de València have provided evidence to improve the definitive coverage of large burns that do not have sufficient donor skin and require skin cultures for survival with the use of a synthetic nanofibrous veil that acts as a scaffold to attach the artificial skin to the affected burned surface.
In the study titled ‘Electrospun poly (hydroxybutyrate) scaffols promote engrafment of human skin equivalents via macrophage M2 polarization and angiogenesis’, published in the Journal of Tissue Engineering and Regenerative Medicine, researchers advance in one of the ‘biggest challenges’ in treatment of patients with large burns: the firing and definitive coverage of the skin in the affected area.
The work provides evidence on the efficacy of the use of biosynthetic scaffolds generated by electrowire for these cases of large burns. The results of the study put on the table a new option for the usual complications in the treatment of these patients and open the door to a clinical trial in late 2017, according to the Generalitat reported in a statement.
The key is to use a biosynthetic nanofibers veil that acts as a scaffold to attach the artificial skin to the burned surfaces. The material has been tuned by AITEX with electro-polishing technology, a technique that consists of the manufacture of fibers at nanometer scale, through electric fields and with a great variety of biomedical applications.
Among them, the formation of fiber systems that support active principles that are dosed controlled or as scaffolds in regenerative tissues and dermal equivalents (ED) formed by keratinocytes and human dermal fibroblasts expanded in vitro to regenerate the skin.
WORKED TO REGENERATE CARDIAC TISSUE
The IIS Regeneration and Transplantation Group La Fe has expertise in the use of polyhydroxybutyrate (PHB), a biomaterial compatible with cardiac tissue that can serve to deposit progenitor cells in an infarcted heart. Once it was verified that the material worked in the regeneration of cardiac tissue, it was decided to test its effectiveness in the skin with the collaboration of the Burn Unit of the Hospital Università i Politècnic La Fe de València.
A humanized mouse model was started and with a small biopsy of human skin expanded in culture plate and attached to the animal, it was possible to create human skin on which a set of dermal equivalent (ED) and PHB veil was grafted . The result was an increase in vascularity favorable to the onset and survival of human skin culture.
This work presents positive results as validation model since it shows that the culture of the human skin, a very fragile material, “better fits with a support or scaffold of nanofibres that favors the vascularization without adverse inflammatory reaction”. It is a first step to evaluate what biomaterials help in the regeneration of the skin in burns and ulcers.
FROM BASIC RESEARCH TO CLINICAL APPLICATION
The clinical challenge of this research is to obtain, with a minimum sample of skin of a large burned patient (more than 50% of body surface burned), the sufficient amount of equivalent
dermal or laboratory skin that can attach to the biosynthetic nanofibers web in the injured areas.
One of the biggest problems facing plastic surgeons when there is not enough skin donor area is that expanded skin in culture has “very little consistency.” Therefore, a support of nanofibres, a biosynthetic scaffold that is biodegradable and that maintains the stability until the crop is needed, is necessary.
The cutaneous cover after the removal of dead tissue in large burnings can be done with cadaver skin from the tissue bank, but this is not a definitive solution. When the plastic surgeon does not have enough donor skin, he should resort to expanded skin.
The study demonstrates that for the skin to garnish with the necessary consistency, PHB nanofibers’ veils play a “key” role in the goal of regaining proper skin properties such as organ barrier function, fluid retention, infections, as well as in the restoration of elasticity and aesthetic function in the skin cover.
In this preclinical phase the biomaterial has been tested to check that it is biocompatible and it has been confirmed that its presence in the dermal environment favors the formation of blood vessels and helps in the resolution of inflammation.
So far, the only limitation of this material is that the polymer (PHB), which is used to weave the veil, is produced by bacteria and, although not toxic, it is not clinically tested. It is the same polymer that is used to make food-grade biodegradable plastic.
Source: SECPRE Press Review