Development of a terminally sterilised decellularised dermis

Many of the decellularised dermis products on the market at present are aspectically produced. NHS Blood and Transplant Tissue Services have developed a method of producing a dCELL human dermis which has been terminally sterilised by gamma irradiation. The terminally sterilised decellularised dermis was compared with cellular tissue and examined for histology, residual DNA content, biomechanical and biochemical properties, in vitro cytotoxicity and in vivo implantation in a mouse model. No alterations in morphology as viewed by light microscopy were observed and DNA removal was 99%. There were no significant changes in ultimate tensile stress or evidence for collagen denaturation or cytotoxicity. The in vivo studies did not indicate any adverse tissue reactions in the mouse model and demonstrated incorporation of dCELL human dermis into the host. Decellularisation, followed by terminal sterilisation with gamma irradiation, is an appropriate method to produce a human dermis allograft material suitable for transplantation.