研究業績

    2024
  • ＜原著論文＞
  • Bando K, Kusakawa S (co-first author), Adachi H, Yamamoto M, Iwata M, Kitanaka A, Ogimura E, Osada T, Tamura M, Terai O, Watanabe T, Yoda T, Yotsumoto T, Zaizen K, Sato Y: Protocol improvement and multisite validation of a digital soft agar colony formation assay for tumorigenic transformed cells intermingled in cell therapy products. Cytotherapy, 2024, in press.

  • Kuroda T, Yasuda S, Matsumayama S, Miura T, Sawada R, Matsuyama A, Yamamoto Y, Morioka MS, Kawaji H, Kasukawa T, Itoh M, Akutsu H, Kawai J, Sato Y: ROR2 expression predicts human induced pluripotent stem cell differentiation into neural stem/progenitor cells and GABAergic neurons. Sci Rep, 2024;14(1):690.

      • 2023
    • ＜原著論文＞
    • Hirai T, Kataoka K, Yuan Y, Yusa K, Sato Y, Uchida K, Kono K: Evaluation of next-generation sequencing performance for in vitro detection of viruses in biological products. Biologicals, 2023;85:101739.

    • Miura T, Kouno T (co-first author), Takano M, Kuroda T, Yamamoto Y, Kusakawa S, Morioka MS, Sugawara T, Hirai T, Yasuda S, Sawada R, Matsuyama S, Kawaji H, Kasukawa T, Itoh M, Matsuyama A, Shin JW, Umezawa A, Kawai J, Sato Y: Single-Cell RNA-Seq Reveals LRRC75A-Expressing Cell Population Involved in VEGF Secretion of Multipotent Mesenchymal Stromal/Stem Cells Under Ischemia. Stem Cells Transl Med, 2023;12(6):379-390.

    • Watanabe T, Yasuda S, Chen CL, Delsing L, Fellows MD, Foldes G, Kusakawa S, Mouries LP, Sato Y: International evaluation study of a highly efficient culture assay for detection of residual human pluripotent stem cells in cell therapies. Regen Med, 2023;18(3):219-227.

    • ＜総説＞
    • Hirai T, Yasuda S, Umezawa A, Sato Y: Country-specific regulation and international standardization of cell-based therapeutic products derived from pluripotent stem cells. Stem Cell Rep, 2023;18(8):1573-1591.

    • 田中直子, 阿部浩幸, 荒木紀帆, 石井匡, 上野高嗣, 黒田拓也, 佐治大介, 中村和靖, 南保泰希, 西田仁, 坂東清子, 藤田大樹, 松浦哲也, 三浦巧, 三木健次, 望月秀美, 安田智, 吉本将成, 渡辺夏巳, 佐藤陽治：細胞加工製品の腫瘍形成リスクの合理的評価を目指して(1). 再生医療, 2023;1:30-35.

    • 樋口ゆり子, 草森浩輔, 佐藤陽治, 坂東博人: 薬剤学で切り拓く創薬モダリティの未来（3）細胞医薬・細胞製剤の現状と薬剤学で切り拓く未来. 薬剤学, 2023;83:19-24.

    • ＜単行本＞
    • 田埜慶子, 佐藤陽治: ヒト細胞加工製品のQbD製造のためのin vitro細胞特性解析. 実験医学増刊 真の実臨床応用をめざした再生医療 2023, （株）羊土社, pp.67-70 (2023)

      2022
    • ＜原著論文＞
    • Hirai T, Kono K, Kusakawa S, Yasuda S, Sawada R, Morishita A, Hata S, Wakita A, Kageyama T, Takahashi R, Watanabe S, Shiraishi N, Sato Y: Evaluation of the reproducibility and positive controls of cellular immortality test for the detection of immortalized cellular impurities in human cell-processed therapeutic products. Regen Ther, 2022;21:540-546.

    • Hirasawa R, Takakura M, Hirai T, Kono K, Sato Y: Attitude and perception survey for the Japanese pharmaceutical industry to utilize next-generation sequencing for virus safety assessment of biologics. Translat Regulat, 2022;4:61-67.

    • Watanabe T, Yasuda S, Chen CL, Delsing L, Fellows MD, Foldes G, Kusakawa S, Mouries LP, Sato Y: International evaluation study of a highly efficient culture assay for detection of residual human pluripotent stem cells in cell therapies. Regenerative Medicine, 2022;18:219-227.

    • Oda S, Nishiyama K, Furumoto Y, Yamaguchi Y, Nishimura A, Tang X, Kato Y, Numaga-Tomita T, Kaneko T, Mangmool S, Kuroda T, Okubo R, Sanbo M, Hirabayashi M, Sato Y, Nakagawa Y, Kuwahara K, Nagata R, Iribe G, Mori Y, Nishida M: Myocardial TRPC6-mediated Zn2+ influx induces beneficial positive inotropy through β-adrenoceptors. Nat Commun, 2022;13:6374.

    • Shirasago Y, Fukazawa H, Nagase S, Shimizu Y, Mizukami T, Wakita T, Suzuki T, Tani H, Kondoh M, Kuroda T, Yasuda S, Sato Y, Hanada K, Fukasawa M: A single mutation in the E2 glycoprotein of hepatitis C virus broadens the claudin specificity for its infection. Sci Rep, 2022;24:20243.

    • Yamamoto T, Sato Y, Yasuda S, Shikamura M, Tamura T, Takenaka C, Takasu N, Nomura M, Dohi H, Takahashi M, Mandai M, Kanemura Ym Nakamura M, Okano H, Kawamata S: Correlation Between Genetic Abnormalities in Induced Pluripotent Stem Cell-Derivatives and Abnormal Tissue Formation in Tumorigenicity Tests. Stem Cells Transl Med, 2022;11:527-538.

    • ＜総説＞
    • Andrews PW, Barbaric I, Benvenisty N, Draper JS, Ludwig T, Merkle FT, Sato Y, Spits C, Stacey GN, Wang H, Pera MF: The consequences of recurrent genetic and epigenetic variants in human pluripotent stem cells. Cell Stem Cell, 2022;29:1624-1636.

    • Tsuchiya A, Terai S, Horiguchi I, Homma Y, Saito A, Nakamura N, Sato Y, Ochiya T, Kino-oka M: Working Group of Attitudes for Preparation and Treatment of Exosomes of Japanese Society of Regenerative Medicine: Basic points to consider regarding the preparation of extracellular vesicles and their clinical applications in Japan. Regen Ther, 2022;21:19-24.

    • 高田のぞみ, 佐藤陽治: 再生医療におけるわが国の法令および規制. 日本医師会雑誌, 2022;151:556.

    • 佐藤陽治: ヒト細胞加工製品の製造におけるin vitro細胞特性評価の重要性. PHARM STAGE, 2022;22:1-3.

    • 平井孝昌, 佐藤陽治: 遺伝子改変されたブタ心臓のヒトへの移植について. 医薬品医療機器レギュラトリーサイエンス, 2022;53:424-426.

      2021
    • ＜原著論文＞
    • Matsuzaka Y, Kusakawa S, Uesawa Y, Sato Y, Sato M: Deep learning-based in vitro detection method for cellular impurities in human cell-processed therapeutic products. Appl Sci, 2021;11(20):9755.

    • Kamiyama Y, Naritomo Y, Moriya Y, Yamamoto S, Kitahashi T, Maekawa T, Yahara M, Hanada T, Uchiyama A, Noumaru A, Koga Y, Higuchi T, Ito M, Komatsu H, Miyoshi S, Kimura S, Umeda N, Fujita E, Tanaka N, Sugita T, Takayama S, Kurogi A, Yasuda S, Sato Y: Biodistribution studies for cell therapy products: Current status and issues. Regen Ther, 2021;18:202-216.

    • Hirai T, Kono K, Sawada R, Kuroda T, Yasuda S, Matsuyama S, Matsuyama A, Koizumi N, Utoguchi N, Mizuguchi H, Sato Y: A selective cytotoxic adenovirus vector for concentration of pluripotent stem cells in human pluripotent stem cell-derived neural progenitor cells. Sci Rep, 2021;11(1):11407.

    • Kono K, Kataoka K, Yuan Y, Yusa K, Uchida K, Sato Y: Infectivity assessment of porcine endogenous retrovirus using high-throughput sequencing technologies. Biologicals, 2021;71:1-8.

    • Miura T, Yasuda S, Sato Y: A simple method to estimate the in-house limit of detection for genetic mutations with low allele frequencies in whole-exome sequencing analysis by next-generation sequencing. BMC Genomic Data, 2021;22:8.

    • Watanabe T, Yasuda S, Kusakawa S, Kuroda T, Futamura M, Ogawa M, Mochizuki H, Kikkawa E, Furukawa H, Nagaoka M, Sato Y: Multisite studies for validation and improvement of a highly efficient culture (HEC) assay for detection of undifferentiated human pluripotent stem cells intermingled in cell therapy products. Cytotherapy, 2021;Feb 23(2):176-183.

      2020
    • ＜原著論文＞
    • Kono K, Kataoka K, Yuan Y, Yusa K, Uchida K, Sato Y: A highly sensitive method for the detection of recombinant PERV-A/C env RNA using next generation sequencing technologies. Sci Rep, 2020:10:21935.

    • Umezawa A, Sato Y, Kusakawa S, Amagase R, Akutsu H, Nakamura K, Kasahara M, Matsubara Y, Igarashi T: Research and development strategy for future embryonic stem cell-based therapy in Japan. JMA Journal, 2020; DOI: 10.31662/jmaj.2018-0029.

    • ＜総説＞
    • 早川堯夫，青井貴之，梅澤明弘，岡田潔，小澤敬也，澤芳樹，嶽北和宏，松山晃文，安田智，大和雅之，佐藤陽治：「ヒト幹細胞加工再生医療製品の品質及び安全性等評価に共通の基本となる技術要件・基準・留意事項」（ミニマム・コンセンサス・パッケージ：MCP）の策定とその活用について．再生医療 2020;19(4):409-448.

    • 澤田留美，佐藤陽治：再生医療等製品(細胞加工製品)の原料等としてのMSC(間葉系幹細胞/間葉系間質細胞)の品質特性解析の問題点―開発企業へのアンケート調査から見えてきたこと―．再生医療 2020;19(2):164-176.

    • 梅澤明弘，佐藤陽治：NRMDをご存知ですか？．再生医療 2020;19(2):123.

    • 我妻昭彦，渡辺武志，糀谷高敏，福原良文，安田智，佐藤陽治：ヒト多能性幹細胞由来の再生医療開発における造腫瘍性評価に関する日米欧三極の規制の状況．医薬品医療機器レギュラトリーサイエンス 2020;51:256-262.

    • 田埜慶子，佐藤陽治：ヒトiPS細胞加工製品の造腫瘍性評価法の開発．実験医学 2020;38:29-34.

    • 田埜慶子，佐藤陽治：不均一性の評価 ―ヒトMSC加工製品（ヒト間葉系幹細胞加工製品/ヒト間葉系間質細胞加工製品）の品質管理にかかる課題―．医学のあゆみ 2020;272:1082-5.

    • 草川森士，佐藤陽治：世界における間葉系幹細胞利用製品の開発動向−ClinicalTrials.govに登録された臨床兼の分析より．医学のあゆみ 2020;272:1093-101.

    • 佐藤陽治，嶽北和宏：再生医療のいまと未来第8回：細胞加工製品における品質の考え方（3/3）．Pharm Tech Japan 2020;36:655-657.

    • 佐藤陽治，嶽北和宏：再生医療のいまと未来第7回：細胞加工製品における品質の考え方（2/3）．Pharm Tech Japan 2020;36:277-280.

    • 佐藤陽治，嶽北和宏：再生医療のいまと未来第6回：細胞加工製品における品質の考え方（1/3）．Pharm Tech Japan 2020;36:117-120.

    • ＜単行本＞
    • 平井孝昌，草川森士，佐藤陽治：再生医療等製品における非臨床試験時のデザイン設計．「再⽣医療等製品/遺伝⼦治療⽤製品の承認取得/審査の視点と実務戦略」，サイエンス＆テクノロジー株式会社（東京），pp.79-104 (2020.9.29)

      2019
    • ＜原著論文＞
    • Ohashi F, Miyagawa S, Yasuda S, Miura T, Kuroda T, Itoh M, Kawaji H, Ito E, Yoshida S, Saito A, Sameshima T, Kawai J, Sawa Y, Sato Y: CXCL4/PF4 is a predictive biomarker of cardiac differentiation potential of human induced pluripotent stem cells. Sci Rep, 2019:9:4638.

    • Kono K, Sawada R, Kuroda T, Yasuda S, Matsuyama S, Matsuyama A, Mizuguchi H, Sato Y: Development of selective cytotoxic viral vectors for concentration of undifferentiated cells in cardiomyocytes derived from human induced pluripotent stem cells. Sci Rep, 2019 Mar 6;9(1):3630.

    • Ito E, Miyagawa S, Takeda M, Kawamura A, Harada A, Iseoka H, Yajima S, Sougawa N, Mochizuki-Oda N, Yasuda S, Sato Y, Sawa Y: Tumorigenicity assay essential for facilitating safety studies of hiPSC-derived cardiomyocytes for clinical application. Sci Rep, 2019;9:1881.

    • Kuroda T, Yasuda S, Tachi S, Matsuyama S, Kusakawa S, Tano K, Miura T, Matsuyama A, Sato Y: SALL3 expression balance underlies lineage biases in human induced pluripotent stem cell differentiation. Nat Commun, 2019;10:2175.

    • ＜総説・解説＞
    • Sato Y, Bando H, Di Piazza M, Gowing G, Herberts C, Jackman S, Leoni G, Libertini S, MacLachlan T, McBlane JW, Pereira Mouriès L, Sharpe M, Shingleton W, Surmacz-Cordle B, Yamamoto K, van der Laan JW: Tumorigenicity assessment of cell therapy products: The need for global consensus and points to consider. Cytotherapy, 2019;21:1095-111.

    • 川崎ナナ，内田恵理子，佐藤陽治，田辺光男，宮田直樹．薬の名前 続：ステムを知れば薬がわかる（第14回）．Pharm Tech Japan, 2019;35:1559-67.

    • 河野健：次世代シーケンシングによるバイオ医薬品等のウイルス安全性評価（番外編２）：2019 PDA Virus Safety Forum参加報告. Pharm Tech Japan, 2019;35,2087-92.

    • 安田智：造腫瘍性関連試験法の現状．PHARM STAGE, 2019;19:1-3.

    • 田埜慶子，佐藤陽治：新しい医薬としての細胞加工製品の品質・安全性の確保．MEDCHEM NEWS, 2019;29:133-7.

    • 佐藤陽冶：リアルワールドデータ．再生医療, 2019;18:431-2.

    • 坂東博人，佐藤陽冶，吉田俊彦，柴田孝，下山敦子，藤井麻衣子，久保田幸治，佐藤卓朋，秋吉竜太郎，辻本伸治，安武幹智，下野知性，國里篤志，渡辺夏巳：ヒト人工多能性幹細胞加工製品の造腫瘍性に関して品質評価・非臨床評価の観点から考慮すべきポイント．再生医療, 2019;18:328-37.

    • 岡田潔，佐藤陽冶，田畑泰彦，畠賢一郎，森尾友宏，八代嘉美：座談会 ナショナルコンソーシアムとは何か？．再生医療, 2019;18:125-33.

    • 佐藤陽冶，嶽北和宏：対談 再生医療のいまと未来　第5回　細胞加工製品における品質の考え方．Pharm Tech Japan, 2019;36,117-20, 277-80, 655-57.

    • 嶽北和宏，安田智：学会印象記「第3回DIA再生医療製品・遺伝子治療用製品シンポジウム」 再生医療, 2019;18:56-57．

    • ＜単行本＞
    • 澤田留美：“関節・軟骨の再生医療”，第11 章　関節・軟骨再生医療等製品の品質及び安全性評価の指標，佐藤正人監修，（株）シーエムシー出版，東京，pp.232-42 (2019)

      2018
    • ＜原著論文＞
    • Nishimura A, Shimauchi T, Tanaka T, Shimoda K, Toyama T, Kitajima N, Ishikawa T, Shindo N, Numaga-Tomita T, Yasuda S, Sato Y, Kuwahara K, Kumagai Y, Akaike T, Ide T, Ojida A, Mori Y, Nishida M: Hypoxic stress-induced interaction of filamin/actin cytoskeleton with Drp1 causes mitochondrial hyperfission-associated myocardial senescence. Sci Signal, 2018;11:eaat5158.

    • Yasuda S, Kusakawa S, Kuroda T, Miura T, Tano K, Takada N, Matsuyama S, Matsuyama A, Nasu M, Umezawa A, Hayakawa T, Tsutsumi H, Sato Y: Tumorigenicity-associated characteristics of human iPS cell lines. PLOS ONE, 2018;13:e0205022.

    • Lysaght T, Munsie M, Castricum A, Hui JHP, Okada K, Sato Y, Sawa Y, Stewart C, Tan LK, Tan LHY, Sugii S: A roundtable on responsible innovation with autologous stem cells in Australia, Japan and Singapore. Cytotherapy, 2018 20(9):1103-09.

    • ＜総説・解説＞
    • Okada K, Sato Y, Sugiyama D, Sawa Y: Establishment of the National Consortium for Regenerative Medicine and National Regenerative Medicine Database in Japan. Clin Ther, 2018 40(7):1076-83.

    • 佐藤陽治：OPINION 再生医療等臨床データシステムNRMD．再生医療, 2018; 17(4), 377.

    • 澤田留美，佐藤陽治：再生医療等製品に関する品質・安全性評価の規制動向．PHARM STAGE, 2018; 18: 26-31.

    • ＜単行本＞
    • 田埜慶子，佐藤陽治：“再生医療・細胞治療の細胞製造のための指針・ガイドラインの動向と実務解釈”，ヒト細胞加工物の品質・安全性確保のための技術要件に関するミニマム・コンセンサス・パッケージ（MCP），水谷学監修，（株）情報機構，東京，pp.3-23（2018）

      2017
    • ＜原著論文＞
    • Kuroda T, Yasuda S, Nakashima H, Takada N, Matsuyama S, Kusakawa S, Umezawa A, Matsuyama A, Kawamata S, Sato Y: Identification of a Gene Encoding Slow Skeletal Muscle Troponin T as a Novel Marker for Immortalization of Retinal Pigment Epithelial Cells. Sci Rep, 2017;7:8163-8174.

    • ＜総説・解説＞
    • 佐藤陽治：細胞加工製品・特定細胞加工物の造腫瘍性．再生医療, 2017; 16(3), 234.

    • 五十嵐友香, 佐藤陽治：RMAT指定制度：細胞加工製品の上市を加速するための米国の新しい取り組み．再生医療, 2017; 16(4), 358-364.

    • ＜単行本＞
    • 三浦巧：“再生医療と医事法（医事法講座第8巻）”, 米国における再生医療の規制の動向とヒトES細胞の医療応用の現状, 信山社, 東京, pp.121-133（2017）

      2016
    • ＜原著論文＞
    • Numaga-Tomita T, Kitajima N, Kuroda T, Nishimura A, Miyano K, Yasuda S, Kuwahara K, Sato Y, Ide T, Birnbaumer L, Sumimoto H, Mori Y, Nishida M: TRPC3-GEF-H1 axis mediates pressure overload-induced cardiac fibrosis. Sci Rep, 2016; 6: 39383.

    • Kitajima N, Numaga-Tomita T, Watanabe M, Kuroda T, Nishimura A, Miyano K, Yasuda S, Kuwahara K, Sato Y, Ide T, Birnbaumer L, Sumimoto H, Mori Y, Nishida M: TRPC3 positively regulates reactive oxygen species driving maladaptive cardiac remodeling. Sci Rep, 2016; 6: 37001.

    • Hayakawa T, Harris I, Joung J, Kanai N, Kawamata S, Kellathur S, Koga J, Lin YC, Maruyama Y, McBlane J, Nishimura T, Renner M, Ridgway A, Salmikangas P, Sakamoto N, Sato D, Sato Y, Toda Y, Umezawa A, Werner M, Wicks S: Report of the International Regulatory Forum on Human Cell Therapy and Gene Therapy Products. Biologicals, 2016; 44(5): 467-479.

    • Hasebe-Takada N, Kono K (co-first author), Yasuda S, Sawada R, Matsuyama A, Sato Y: Application of cell growth analysis to the quality assessment of human cell-processed therapeutic products as a testing method for immortalized cellular impurities. Regen Ther, 2016; 5, 49-54.

    • Kono K, Hiruma H, Kobayashi S, Sato Y, Tanaka M, Sawada R, Niimi S: In Vitro endothelialization test of biomaterials using immortalized endothelial cells. PLoS ONE, 2016; 11(6): e0158289.

    • Tohyama S, Fujita J, Hishiki T, Matsuura T, Hattori F, Ohno R, Kanazawa H, Seki T, Nakajima K, Kishino Y, Okada M, Hirano A, Kuroda T, Yasuda S, Sato Y, Yuasa S, Sano M, Suematsu M, Fukuda K: Glutamine oxidation is indispensable for survival of human pluripotent stem cells. Cell Metab, 2016; 23: 663-674.

    • ＜総説・解説＞
    • 佐藤陽治：再生医療等に使用される細胞加工物の品質・安全性評価―リスクベースアプローチの考え方―．バイオインダストリー，2016;33:54-64.

    • 佐藤陽治：生物由来原料基準．再生医療，2016;15:89-90.

    • 添田麻由実，佐藤陽治：再生医療に関するわが国の法規制と海外の規制について．医薬品医療機器レギュラトリーサイエンス，2016;47:86-92.

    • 佐藤陽治：再生医療等製品の製品化に大切なこと・・・品質の確保をどうするか―改正薬事法施行に向けた，ガイダンス等の整備状況と解説．臨床医薬，2016;32:89-95.

    • ＜単行本＞
    • 三浦巧，佐藤陽治：“細胞培養の基礎知識と細胞培養基材の利用・開発の留意点”, 実験用の細胞培養と臨床用の細胞培養（製造）の違いと考え方, （株）情報機構, 東京, pp.70-84（2016）

    • 安田智，佐藤陽治：“造腫瘍性評価”，再生医療・細胞治療のための細胞加工物評価技術，（株）シーエムシー出版，東京，pp.45-53（2016）

    • 安田智，佐藤陽治：“GCTP省令と治験薬GMPとの関連性”，　治験薬GMPに対応した製造・品質管理のコツ，（株）技術情報協会，東京，pp.349-352（2016）

    • 草川森士，佐藤陽治：“第３章 再生医療等製品における非臨床試験時の試験デザイン設計”，再生医療等製品の承認取得要件への対応と実務戦略，サイエンス&テクノロジー（株），東京，pp.37-59（2016）

    • 田埜慶子，佐藤陽治：臨床薬学テキストシリーズ　バイオ医薬品と再生医療（乾賢一　監修）第２章　再生医療の実用化促進のための新たな法律とレギュラトリーサイエンス，（株）中山書店，東京，pp.152-161 (2016)

    • 遊佐敬介：有効性・安全性確保のためのバイオ医薬品の品質管理戦略（川西徹，川崎ナナ 監修 ）第４章品質管理 Ⅲ ウイルス安全性，（株）じほう，東京，pp.124-129 (2015)

    • 佐藤陽治：再生医療のための細胞製造ハンドブック（紀ノ岡正博　監修）（株）シ－エムシー出版，東京，pp. 146-158 (2015)

      2015
    • ＜原著論文＞
    • Maeda Y, Terasawa H, Tanaka Y, Mitsuura C, Nakashima K, Yusa K, Harada S: Separate cellular localizations of human T-lymphotropic virus 1 (HTLV-1) Env and glucose transporter type 1 (GLUT1) are required for HTLV-1 Env-mediated fusion and infection. J Virol, 2015;89:502-511.

    • Kusakawa S, Yasuda S, Kuroda T, Kawamata S, Sato Y: Ultra-sensitive detection of tumorigenic cellular impurities in human cell-processed therapeutic products by digital analysis of soft agar colony formation. Sci Rep, 2015;5:17892.

    • Kuroda T, Yasuda S, Matsuyama S, Tano K, Kusakawa S, Sawa Y, Kawamata S, Sato Y: Highly sensitive droplet digital PCR method for detection of residual undifferentiated cells in cardiomyocytes derived from human pluripotent stem cells. Regen Ther, 2015;2:17-23.

    • Hayakawa T, Aoi T, Umezawa A, Ozawa K, Sato Y, Sawa Y, Matsuyama A, Yamanaka S, Yamato M: A study on ensuring the quality and safety of pharmaceuticals and medical devices derived from the processing of autologous human somatic stem cells. Regen Ther, 2015;2:57-69.

    • Hayakawa T, Aoi T, Umezawa A, Ozawa K, Sato Y, Sawa Y, Matsuyama A, Yamanaka S, Yamato M: A study on ensuring the quality and safety of pharmaceuticals and medical devices derived from the processing of allogeneic human somatic stem cells. Regen Ther, 2015;2:70-80.

    • Hayakawa T, Aoi T, Umezawa A, Ozawa K, Sato Y, Sawa Y, Matsuyama A, Yamanaka S, Yamato M: A study on ensuring the quality and safety of pharmaceuticals and medical devices derived from processing of autologous human induced pluripotent stem(-like) cells. Regen Ther, 2015;2:81-94.

    • Hayakawa T, Aoi T, Umezawa A, Ozawa K, Sato Y, Sawa Y, Matsuyama A, Yamanaka S, Yamato M: A study on ensuring the quality and safety of pharmaceuticals and medical devices derived from processing of allogeneic human induced pluripotent stem(-Like) cells. Regen Ther, 2015;2:95-108.

    • Hayakawa T, Aoi T, Umezawa A, Ozawa K, Sato Y, Sawa Y, Matsuyama A, Yamanaka S, Yamato M: A study on ensuring the quality and safety of pharmaceuticals and medical devices derived from the processing of human embryonic stem cells. Regen Ther, 2015;2:109-122.

    • Takeda E, Kono K, Hulme AE, Hope TJ, Nakayama EE, Shioda T: Fluorescent Image Analysis of HIV-1 and HIV-2 Uncoating Kinetics in the Presence of Old World Monky TRIM5α. PLoS ONE, 2015;10:e0121199.

    • Kono K, Takada N (co-first author), Yasuda S, Sawada R, Niimi S, Matsuyama A, Sato Y: Characterization of the cell growth analysis for detection of immortal cellular impurities in human mesenchymal stem cells. Biologicals, 2015;43:146-9.

    • Maeda Y, Terasawa T, Tanaka Y, Mitsuura C, Nakashima K, Yusa K, Harada S: Separate Cellular Localizations of Human T-Lymphotropic Virus 1 (HTLV-1) Env and Glucose Transporter Type 1 (GLUT1) Are Required for HTLV-1 Env-Mediated Fusion and Infection. J Virol, 2015;89:502-11.

    • Kusakawa S, Machida K, Yasuda S, Takada N, Kuroda T, Sawada R, Okura H, Tsutsumi H, Kawamata S, Sato Y: Characterization of in vivo tumorigenicity tests using severe immunodeficient NOD/Shi-scid IL2Rgnull mice for detection of tumorigenic cellular impurities in human cell-processed therapeutic products. Regen Ther, 2015;1:30-7.

    • Tano K, Yasuda S, Kuroda T, Saito H, Umezawa A, Sato Y: A Novel In Vitro Method for Detecting Undifferentiated Human Pluripotent Stem Cells as Impurities in Cell Therapy Products Using a Highly Efficient Culture System. PLoS ONE, 2014;9:e110496.

    • Kuroda T, Yasuda S, Sato Y: In vitro detection of residual undifferentiated cells in retinal pigment epithelial cells derived from human induced pluripotent stem cells. Methods Mol Biol, 2014;1210:183-92.

    • ＜総説・解説＞
    • 畠賢一郎，佐藤陽治，鈴木邦彦，宮田俊男，森尾友宏，横川拓哉：（座談会）新制度は再生医療に何をもたらすか．再生医療，2015;14:9-16.

    • 三浦巧：ゼノフリー．再生医療，2015;14:52-53.

    • 遊佐敬介，前田洋助，苑 宇哲：バイオ医薬品製造用CHO細胞に汚染事例を引き起こしたベシウイルス2117について．医薬品医療機器レギュラトリーサイエンス，2015;46:556-559.

    • 村岡ひとみ，佐藤陽治：再生医療の実用化・産業化に向けた新しい法規制．腎と透析，2015;79:872-876.

    • Hayakawa T, Aoi T, Bravery C, Hoogendoorn K, Knezevic I, Koga J, Maeda D, Matsuyama A, McBlane J, Morio T, Petricciani J, Rao M, Ridgway A, Sato D, Sato Y, Stacey G, Sakamoto N, Trouvin JH, Umezawa A, Yamato M, Yano K, Yokote H, Yoshimatsu K, Zorzi-Morre P: Report of the international conference on regulatory endeavors towards the sound development of human cell therapy products. Biologicals, 2015;43:283-97.

    • Yasuda S, Sato Y: Tumorigenicity assessment of human cell-processed therapeutic products. Biologicals, 2015;43:416-21.

    • 早川堯夫，佐藤陽治：わが国の再生医療実用化促進の規制整備と世界での位置づけ．再生医療，2015;14:225-41.

    • 澤田留美：再生医療等製品とバイオマテリアル，そして評価指標．バイオマテリアル―生体材料―，2015;33:7-8.