title: Biological safety of fish (tilapia) collagen.
abstract: Marine collagen derived from fish scales, skin, and bone has been widely investigated for application as a scaffold and carrier due to its bioactive properties, including excellent biocompatibility, low antigenicity, and high biodegradability and cell growth potential. Fish type I collagen is an effective material as a biodegradable scaffold or spacer replicating the natural extracellular matrix, which serves to spatially organize cells, providing them with environmental signals and directing site-specific cellular regulation. This study was conducted to confirm the safety of fish (tilapia) atelocollagen for use in clinical application. We performed in vitro and in vivo biological studies of medical materials to investigate the safety of fish collagen. The extract of fish collagen gel was examined to clarify its sterility. All present sterility tests concerning bacteria and viruses (including endotoxin) yielded negative results, and all evaluations of cell toxicity, sensitization, chromosomal aberrations, intracutaneous reactions, acute systemic toxicity, pyrogenic reactions, and hemolysis were negative according to the criteria of the ISO and the Ministry of Health, Labour and Welfare of Japan. The present study demonstrated that atelocollagen prepared from tilapia is a promising biomaterial for use as a scaffold in regenerative medicine.
authors.affiliation: Department of Cariology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8588, Japan.
authors.forename: Kohei
authors.initials: K
authors.lastname: Yamamoto
authors.affiliation: Department of Cariology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8588, Japan.
authors.forename: Kazunari
authors.identifier: 0000-0002-9304-4875
authors.initials: K
authors.lastname: Igawa
authors.affiliation: Department of Cariology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8588, Japan.
authors.forename: Kouji
authors.initials: K
authors.lastname: Sugimoto
authors.affiliation: Department of Cariology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8588, Japan.
authors.forename: Yuu
authors.initials: Y
authors.lastname: Yoshizawa
authors.affiliation: Department of Cariology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8588, Japan.
authors.forename: Kajiro
authors.initials: K
authors.lastname: Yanagiguchi
authors.affiliation: Department of Cariology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8588, Japan.
authors.forename: Takeshi
authors.identifier: 0000-0002-5762-7387
authors.initials: T
authors.lastname: Ikeda
authors.affiliation: Department of Cariology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8588, Japan.
authors.forename: Shizuka
authors.identifier: 0000-0001-5346-5627
authors.initials: S
authors.lastname: Yamada
authors.affiliation: Department of Cariology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8588, Japan.
authors.forename: Yoshihiko
authors.identifier: 0000-0002-4256-3085
authors.initials: Y
authors.lastname: Hayashi
mesh_terms: D000818:Animals; D001831:Body Temperature / Q000187:drug effects; D048430:Cell Shape / Q000187:drug effects; D003094:Collagen / Q000633:toxicity*; D006224:Cricetinae; D003412:Cricetulus; D005109:Extracellular Matrix / Q000187:drug effects / Q000378:metabolism; D006168:Guinea Pigs; D008297:Male; D011817:Rabbits; D012867:Skin / Q000187:drug effects; D013242:Sterilization; D017210:Tilapia / Q000378:metabolism*; D018675:Toxicity Tests
chemical_list: C059821:atelocollagen; D003094:Collagen