title: 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.
abstract: 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.
authors.affiliation: Department of Plastic and Reconstructive Surgery, Graduate School of Medicine, Kyoto University, Kyoto, JapanDepartment of Experimental Therapeutics, Translational Research Center, Kyoto University Hospital, Kyoto, JapanCenter for Cell and Molecular Therapy, Kyoto University Hospital, Kyoto, JapanDepartment of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, Kyoto, JapanDepartment of Clinical Innovative Medicine, Translational Research Center, Kyoto University Hospital, Kyoto, Japan.
authors.forename: Naoki
authors.initials: N
authors.lastname: Morimoto
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Ito
authors.forename: Satoru
authors.initials: S
authors.lastname: Takemoto
authors.forename: Mikiko
authors.initials: M
authors.lastname: Katakami
authors.forename: Norikazu
authors.initials: N
authors.lastname: Kanda
authors.forename: Harue
authors.initials: H
authors.lastname: Tada
authors.forename: Shiro
authors.initials: S
authors.lastname: Tanaka
authors.forename: Satoshi
authors.initials: S
authors.lastname: Teramukai
authors.forename: Katsuya
authors.initials: K
authors.lastname: Kawai
authors.forename: Yoko
authors.initials: Y
authors.lastname: Nakamura
authors.forename: Yasunari
authors.initials: Y
authors.lastname: Kasai
authors.forename: Yokode
authors.initials: Y
authors.lastname: Masayuki
authors.forename: Taira
authors.initials: T
authors.lastname: Maekawa
authors.forename: Akira
authors.initials: A
authors.lastname: Shimizu
authors.forename: Shigehiko
authors.initials: S
authors.lastname: Suzuki
mesh_terms: D000368:Aged; D000672:Amputation Stumps; D064592:Autografts; D003470:Culture Media; D017719:Diabetic Foot / Q000601:surgery*; D005347:Fibroblasts / Q000502:physiology; D006097:Granulation Tissue / Q000502:physiology; D006365:Heel; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D017768:Skin, Artificial; D014945:Wound Healing / Q000502:physiology
chemical_list: D003470:Culture Media