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Innovative evaluation methods of chemical afent combination apparatus

Research Project

Project/Area Number 16K01434
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field Medical engineering assessment
Research InstitutionUniversity of Tsukuba

Principal Investigator

Yamazaki Masashi  筑波大学, 医学医療系, 教授 (50281712)

Co-Investigator(Kenkyū-buntansha) 原 友紀  筑波大学, 医学医療系, 講師 (30431688)
Research Collaborator Itou Atsuo  
Mutsuzaki Hirotaka  
Hashimoto Kouichi  
Yamamoto Nobuyuki  
Fujii Kengo  
Yanagisawa Yohei  
Matsumoto Yukei  
Nagashima Katsuya  
Sogo Yu  
Kobayashi Fumiko  
Project Period (FY) 2016-04-01 – 2019-03-31
Project Status Completed (Fiscal Year 2018)
Budget Amount *help
¥4,550,000 (Direct Cost: ¥3,500,000、Indirect Cost: ¥1,050,000)
Fiscal Year 2018: ¥1,820,000 (Direct Cost: ¥1,400,000、Indirect Cost: ¥420,000)
Fiscal Year 2017: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Fiscal Year 2016: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Keywordsコンビネーション医療機器 / 品質評価 / 脊椎インプラント / 臨床研究 / 医療機器品質評価 / 医療機器 / レギュラトリーサイエンス / コンビネーション製品
Outline of Final Research Achievements

We developed screws coated with fibroblast growth factor-2 (FGF-2)-apatite composite layers. We aim to obtain the approval of this growth factor combined screw. The object of this study was to clarify the evaluation method of combination medical equipments.
①The risk of impaired bone formation was evaluated using the Weibull plot analysis.②Establishment of the freeze-dry method and its quality control.③Clinical trial (Feasibility study)

Academic Significance and Societal Importance of the Research Achievements

コンビネーション製品の開発において、よく検証された新たな評価法が必要であるとする発想は過去にない。既承認医療機器に既承認医薬品を添加する場合でも、新たに付加された治療効果は未知のものと捉え、各々の既存の評価法のみで安全性を保証しないことがこの分野の新技術開発に重要であることを本研究で示した。また、研究成果を随時企業や他の開発者が参照できるようにすることで、世界的には出遅れた我が国のコンビネーション製品開発を加速させる効果が期待できる。

Report

(4 results)
  • 2018 Annual Research Report   Final Research Report ( PDF )
  • 2017 Research-status Report
  • 2016 Research-status Report
  • Research Products

    (4 results)

All 2018 2017 2016

All Journal Article (2 results) (of which Int'l Joint Research: 1 results,  Peer Reviewed: 2 results,  Open Access: 2 results) Presentation (2 results)

  • [Journal Article] Initial clinical trial of pins coated with fibroblast growth factor-2-apatite composite layer in external fixation of distal radius fractures.2018

    • Author(s)
      Yanagisawa Y, Ito A, Hara Y, Mutsuzaki H, Murai S, Fujii K, Sogo Y, Hirose M, Oyane A, Kobayashi F, Yamazaki M.
    • Journal Title

      J Orthop.

      Volume: 19 Issue: 1 Pages: 69-73

    • DOI

      10.1016/j.jor.2018.12.012

    • Related Report
      2018 Annual Research Report
    • Peer Reviewed / Open Access / Int'l Joint Research
  • [Journal Article] Reducing the risk of impaired bone apposition to titanium screws with the use of fibroblast growth factor-2-apatite composite layer coating2017

    • Author(s)
      Kengo Fujii, MD; Atsuo Ito, PhD; Hirotaka Mutsuzaki, MD, PhD; Shinji Murai, MD; Yu Sogo, PhD; Yuki Hara, MD, PhD; Masashi Yamazaki, MD, PhD
    • Journal Title

      Journal of Orthopaedic Surgery and Research.

      Volume: 12 Pages: 1-9

    • NAID

      120007135220

    • Related Report
      2017 Research-status Report
    • Peer Reviewed / Open Access
  • [Presentation] FGF-2(線維芽細胞成長因子)担持アパタイトコーティング創外固定ピンのコーティング層の安全性の検討2017

    • Author(s)
      柳澤洋平、原友紀、山崎正志 ほか
    • Organizer
      第90回日本整形外科学会学術集会
    • Related Report
      2017 Research-status Report
  • [Presentation] FGF-2担持アパタイトコーティングチタンスクリューの安定した骨形成作用2016

    • Author(s)
      藤井賢吾、伊藤敦夫、原友紀、六崎裕高,村井伸司,柳澤洋平,長島克弥,松本佑啓,野口裕史,小林文子,十河友,山崎正志
    • Organizer
      第31回(2016年) 日本整形外科学会基礎学術集会
    • Place of Presentation
      福岡国際会議場・福岡県・博多市
    • Year and Date
      2016-10-13
    • Related Report
      2016 Research-status Report

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Published: 2016-04-21   Modified: 2020-03-30  

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