Optimised grafts for severe skin defects

Large full-thickness skin defects resulting from burns and tumour removal, for example, still present significant clinical problems. Use of split-thickness skin, taken from the patient, can result in significant scarring due to possible lack of dermal tissue. Another option, acellular artificial skin available to date, involves at least two operations.

The project EUROSKINGRAFT (A novel generation of skin substitutes to clinically treat a broad spectrum of severe skin defects) is bringing the three novel skin-reconstitution products through clinical trials and then to European and international markets.

Novomaix is an acellular off-the-shelf product that EUROSKINGRAFT expects will improve the pliability of the split-thickness skin grafts. It is slated to provide adequate patient care when the option of a bioengineered graft is not available. Novomaix has received Conformité Européenne (CE) certification and the safety analysis has been completed.

denovoDerm is also designed to be used in conjunction with split-thickness skin in one procedure only. The dermis-like properties of denovoDerm instantly and significantly support the overlying split-thickness skin. The result is a smooth pigmented product that grows with the patient.

At the high end, denovoSkin doesn't need split-thickness skin apart from the small biopsy itself. As a result, considerable trauma for the patient is avoided. For use with both paediatrics and adults, it also grows with the patient and produces excellent cosmetic and functional results.

Phase I of clinical trials for denovoDerm and denovoSkin commenced in June 2014. The first clinical studies suggest that scarring and shrinking are minimal with both products. 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.

In parallel, six types of accessory disposable devices have been extensively tested, packaged and sterilised. Some of these devices are compression-associated; others are cell culture-associated. For the rest of the project term, histological, biochemical and genetic analysis of the products prior to and after transplantation will be ongoing.

The bio-engineered skins are all highly functional and represent the pinnacle of regenerative medicine as applied in the clinic. Generally, the quality of life for a large group of patients requiring skin grafts will be significantly improved. The skin substitutes can be used for treatment of burns, plastic reconstructive surgery and aesthetic procedures. In particular, denovoSkin may be used for chronic wounds such as ulcers and vitiligo where the skin pigment has disappeared.