An exploratory clinical study on the safety and efficacy of an autologous fibroblast-seeded artificial skin cultured with animal product-free medium in patients with diabetic foot ulcers
An exploratory clinical study on the safety and efficacy of an autologous fibroblast-seeded artificial skin cultured with animal product-free medium in patients with diabetic foot ulcers
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DOI：
10.1111/j.1742-481x.2012.01064.x
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发表时间：
2014-04-01
影响因子：
3.1
通讯作者：
Suzuki, Shigehiko
中科院分区：
文献类型：
--
作者：
Morimoto, Naoki;Ito, Tatsuya;Suzuki, Shigehiko
培养的真皮替代品已用于治疗慢性皮肤溃疡;然而，已报告了培养过程中动物源性材料（如胎牛血清（FBS））的生物学风险。在这项研究中，我们准备了一个自体成纤维细胞接种的人工真皮（AFD）使用动物产品的培养基补充2%的患者自体血清和没有任何动物源性材料，如胰蛋白酶在培养过程中。我们将AFD应用于5例糖尿病溃疡患者，并研究其安全性和有效性。作为主要终点，我们根据第21天肉芽面积占整个伤口面积的百分比定义“伤口床改善”，60%或更高被视为改善。患者的平均年龄为60.6岁，溃疡的平均持续时间为22.6个月。在主要终点评价中，所有患者的“伤口床”均得到改善[改善比例：100%，95%置信区间（CI）：48%-100%]。3名患者在施用后12周内伤口完全愈合，2名患者在12周时伤口愈合>80%。副作用不严重。我们的AFD可能是一种安全有效的糖尿病溃疡治疗方法。
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 foetal bovine serum (FBS) have been reported. In this study, 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 the AFD in five patients with diabetic ulcers and investigated its safety and efficacy. As the primary endpoint, we defined 'wound bed improvement' according to the percentage of granulation area to the whole wound area on day 21, and 60% or higher was regarded as improved. The mean age of the patients was 60.6 years and the mean duration of the ulcer was 22.6 months. In the evaluation of the primary endpoint, the 'wound bed' was improved in all patients [proportion of improvement: 100%, 95% confidence interval (CI): 48% to 100%]. Three patients had complete wound healing within 12 weeks after application and two patients had >80% wound healing at 12 weeks. Side effects were not serious. Our AFD may be a safe and effective treatment of diabetic ulcers.