Clinical study using cultured dermal substitutes and cultured skin

培养的真皮替代物已被用于治疗慢性皮肤溃疡；然而，动物来源的材料在培养过程中的生物风险已被报道，如胎牛血清(FBS)。我们使用添加2%患者自体血清的无动物产品的培养液，在培养过程中不使用任何动物源性材料，制备了自体成纤维细胞种植的人工真皮(AFD)。我们将AFD应用于5例糖尿病溃疡，并观察其安全性和有效性。作为主要终点，我们根据形成的肉芽组织面积占整个伤口面积的百分比来定义“伤口床改善”。在主要终点的评估中，所有患者的“伤口床”都得到了改善。副作用不严重。在本研究中，我们尝试使用添加2%患者自体血清的无动物产品的培养液来制备培养的皮肤，这种培养液与通常的添加10%的FBS的培养液没有差别。

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.