Innovative evaluation methods of chemical afent combination apparatus
| Project/Area Number |
16K01434
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Research Field |
Medical engineering assessment
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| Research Institution | University of Tsukuba |
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Principal Investigator |
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| Co-Investigator(Kenkyū-buntansha) |
原 友紀 筑波大学, 医学医療系, 講師 (30431688)
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| Research Collaborator |
Itou Atsuo
Mutsuzaki Hirotaka
Hashimoto Kouichi
Yamamoto Nobuyuki
Fujii Kengo
Yanagisawa Yohei
Matsumoto Yukei
Nagashima Katsuya
Sogo Yu
Kobayashi Fumiko
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| Project Period (FY) |
2016-04-01 – 2019-03-31
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| Project Status |
Completed (Fiscal Year 2018)
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| 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)
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| 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 |
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| 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)
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| 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。
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Report
(4 results)
Research Products
(4 results)
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[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.
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Journal Title
J Orthop.
Volume: 19
Issue: 1
Pages: 69-73
DOI
Related Report
Peer Reviewed / Open Access / Int'l Joint Research
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[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
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Journal Title
Journal of Orthopaedic Surgery and Research.
Volume: 12
Pages: 1-9
NAID
Related Report
Peer Reviewed / Open Access
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