Scar-free grafts repair severe skin defects
The project EUROSKINGRAFT (A novel generation of skin substitutes to clinically treat a broad spectrum of severe skin defects) has prepared the three novel skin-reconstitution products for clinical trials that are at various stages of readiness for European and international markets. Novomaix, an acellular off-the-shelf product and an option when a bioengineered graft is unavailable or when a split skin graft will give inferior results. Novomaix has received Conformité Européenne (CE) certification with safety analysis and phase I studies successfully completed. Phase II trials are close to completion. denovoDerm can also be used in conjunction with split-thickness skin in a single procedure. The result is a smooth pigmented product that grows with the patient. Phase I studies have been completed and clinical trials are due to start in 2017. At the high end, denovoSkin doesn't need split-thickness skin apart from the small biopsy itself. For use with both paediatrics and adults, it also grows with the patient and produces excellent cosmetic and functional results. Phase I trials are complete and the team will now proceed with product development and testing efficacy in phase II multicentric studies. For production of denovoSkin and denovoDerm, five compression devices are now ready for the plastic compression of collagen type I hydrogels under good manufacturing practice conditions. In addition, development of packaging and sterilisation has been completed. Innovative, molecular and biochemical methods were developed to determine the quality of the skin grafts both prior and after transplantation. Furthermore, a new incubator-like transport box was developed in collaboration with SkyCell AG in Switzerland for long term shipping of both skin biopsies and bio-engineered skin grafts. The team filed patents on the skin substitutes and the compression device with commercial marketing awaiting the clinical trial programme results. A costing programme for products manufacture is also available for potential investors. Potential users of the EUROSKINGRAFT products include burn and plastic reconstructive surgeons as well as dermatologists. Only one surgical intervention with these skin substitutes means that patients have a significant improvement in quality of life. Moreover, this is not only more economical but also a less traumatic solution for patients.
Keywords
Grafts, skin defects, skin substitutes, EUROSKINGRAFT, skin-reconstitution