Clinical study using cultured dermal substitutes and cultured skin

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Cultured dermal substitutes have been used for the treatment of chronic skin ulcers ; however, the biological risks of animal-derived materials in the culture process such as fetal bovine serum(FBS) have been reported. We prepared an autologous fibroblast-seeded artificial dermis(AFD) using animal product-free medium supplemented with 2% patient autologous serum and without any animal-derived materials such as trypsin in the culturing process. We applied AFD to five diabetic ulcers and investigated the safety and efficacy. As the primary endpoint, we defined,"wound bed improvement"according to the percentage of formed granulation area to the whole wound area. In the evaluation of the primary endpoint, the"wound bed"was improved in all patients. Side effects were not serious. In this study, we tried to use animal product-free medium supplemented with 2% patient autologous serum for the preparation of cultured skin and there was no difference between this medium and the usual medium supplemented with 10% FBS.