Open AccessAn 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
Author(s) -
Morimoto Naoki,
Ito Tatsuya,
Takemoto Satoru,
Katakami Mikiko,
Kanda Norikazu,
Tada Harue,
Tanaka Shiro,
Teramukai Satoshi,
Kawai Katsuya,
Nakamura Yoko,
Kasai Yasunari,
Masayuki Yokode,
Maekawa Taira,
Shimizu Akira,
Suzuki Shigehiko
Publication year - 2014
Publication title -
international wound journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.867
H-Index - 63
eISSN - 1742-481X
pISSN - 1742-4801
DOI - 10.1111/j.1742-481x.2012.01064.x
Subject(s) - medicine , diabetic foot , dermis , granulation tissue , wound healing , fibroblast , surgery , clinical endpoint , dermal fibroblast , wound dressing , adverse effect , diabetes mellitus , randomized controlled trial , pathology , cell culture , biology , genetics , endocrinology , materials science , composite material
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.