title: Feasibility and limitations of the round robin test for assessment of in vitro chondrogenesis evaluation protocol in a tissue-engineered medical product.
abstract: Tissue-engineered medical products (TEMPs) should be evaluated before implantation. Therefore, it is indispensable to establish evaluation protocols in regenerative medicine. Whether or not such evaluation protocols are reasonable is generally verified through a 'round robin' test. However, the round robin test for TEMPs intrinsically includes a deficiency, because 'identical' specimens can not be prepared for TEMPs. The aim of the study was to assess the feasibility and limitations of the round robin test for TEMPs by using a prepared evaluation protocol. We adopted tissue-engineered cartilage constructs as delivered specimens and a protocol of measuring sGAG content as an evaluation protocol proposed to ISO TC150/SC7, which is an invasive, but usually applied, method, although non-invasive methods are keenly required in evaluating TEMPs. The results showed that: (a) the coefficient of variation (CV) of the measured sGAG contents in intralaboratory tests was ~5% at most; (b) the CV of sGAG content in the scheme where each participating laboratory measured different constructs was comparable with that in the scheme where each participating laboratory measured one half of a construct along with the organizing laboratory; (c) the CV caused by factors other than the specimen was ~15%, comparable to that in reproducible experiments in biomedical fields. Based on these results, the study concludes that a round robin test for a TEMP could be valuable, under the condition that the delivered TEMPs are sufficiently reproducible so that the CV of the measured values is < 5% in the organizing laboratory.
authors.affiliation: Centre for Disease Biology and Integrative Medicine-CDBIM, Graduate School of Medicine, University of Tokyo, Japan.
authors.forename: Masako
authors.initials: M
authors.lastname: Yokoi
authors.forename: Koji
authors.initials: K
authors.lastname: Hattori
authors.forename: Koichi
authors.initials: K
authors.lastname: Narikawa
authors.forename: Hajime
authors.initials: H
authors.lastname: Ohgushi
authors.forename: Mika
authors.initials: M
authors.lastname: Tadokoro
authors.forename: Kazuto
authors.initials: K
authors.lastname: Hoshi
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Takato
authors.forename: Akira
authors.initials: A
authors.lastname: Myoui
authors.forename: Katsuhiko
authors.initials: K
authors.lastname: Nanno
authors.forename: Yukio
authors.initials: Y
authors.lastname: Kato
authors.forename: Masami
authors.initials: M
authors.lastname: Kanawa
authors.forename: Katsura
authors.initials: K
authors.lastname: Sugawara
authors.forename: Tomoko
authors.initials: T
authors.lastname: Kobo
authors.forename: Takashi
authors.initials: T
authors.lastname: Ushida
mesh_terms: D000818:Animals; D001672:Biocompatible Materials / Q000494:pharmacology*; D002417:Cattle; D020219:Chondrogenesis / Q000187:drug effects* / Q000502:physiology*; D005069:Evaluation Studies as Topic; D005240:Feasibility Studies; D005782:Gels; D006025:Glycosaminoglycans / Q000378:metabolism; D007753:Laboratories; D008422:Materials Testing / Q000379:methods*; D023822:Tissue Engineering / Q000379:methods*
chemical_list: D001672:Biocompatible Materials; D005782:Gels; D006025:Glycosaminoglycans