[Autologous cultured skin substitutes]

Abstract

Progress in cell culture and biomaterial technologies has resulted in commercially available autologous and allogeneic skin substitutes that are composed of keratinocytes and/or fibroblats, in part combined with allogeneic (fibrin) or xenogeneic (collagen, hyaluronan) matrix substances. So far, clinical testing of tissue-engineered products focused on chronic wounds (vascular leg ulcers, diabetic foot ulcers); another major indication, however, is large acute skin defects (burns). During the last decade, partly-controlled clinical trials have been performed with several cultured skin substitutes, studying primarily vascular leg ulcers; a few of these products have been approved for defined indications by the regulatory authorities of various countries. To fulfill regulatory requirements and be eligible for reimbursement, safety as well as cost-effectiveness have to be documented for these novel therapies in contrast to established methods for clearly defined clinical settings; this, in combination with restricted health care resources, is actually hampering the clinical breakthrough of tissue engineering in the treatment of skin wounds, despite undiminished research activities.