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Establishment of a world-standard complement test system to establish complement reference values and their clinical application

Research Project

Project/Area Number 20H03580
Research Category

Grant-in-Aid for Scientific Research (B)

Allocation TypeSingle-year Grants
Section一般
Review Section Basic Section 52010:General internal medicine-related
Research InstitutionRakuno Gakuen University

Principal Investigator

Wakamiya Nobutaka  酪農学園大学, 農食環境学群, 特任教授 (20210867)

Co-Investigator(Kenkyū-buntansha) 井上 徳光  和歌山県立医科大学, 医学部, 教授 (80252708)
鈴木 定彦  北海道大学, 人獣共通感染症国際共同研究所, 教授 (90206540)
大谷 克城  酪農学園大学, 農食環境学群, 教授 (90396367)
日高 義彦  和歌山県立医科大学, 医学部, 非常勤講師 (40624713)
Project Period (FY) 2020-04-01 – 2024-03-31
Project Status Completed (Fiscal Year 2023)
Budget Amount *help
¥17,680,000 (Direct Cost: ¥13,600,000、Indirect Cost: ¥4,080,000)
Fiscal Year 2023: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
Fiscal Year 2022: ¥4,680,000 (Direct Cost: ¥3,600,000、Indirect Cost: ¥1,080,000)
Fiscal Year 2021: ¥4,680,000 (Direct Cost: ¥3,600,000、Indirect Cost: ¥1,080,000)
Fiscal Year 2020: ¥6,630,000 (Direct Cost: ¥5,100,000、Indirect Cost: ¥1,530,000)
Keywords補体 / 免疫 / 抗体 / 炎症 / 臨床検査 / ベッドサイト / 自己免疫疾患 / レクチン / 自己免疫性疾患 / コロナウイルス感染 / 世界標準
Outline of Research at the Start

難治性疾患(非典型尿毒症症候群(aHUS)や移植に伴うなどの血栓性微小血管症(TMA)や自己抗体による中枢神経系疾患(重症筋無力症、ギランバレー症候群、視神経脊髄炎)に補体活性化の関与が疑われており、近年抗補体薬(C5分子標的薬)が、これら難病疾患をほぼ完全に沈静化する報告が相次いでいる。しかし、現在、補体の活性化と疾患病態を結びつける適切な補体検査系は日本ばかりか世界でも構築されていない。本研究の目的は、国際標準の20項目の検査体制を構築し、日本人における基準値を提示することであり、補体系の新規検査法や新しい治療薬の基盤的知見を得ることを期待している。

Outline of Final Research Achievements

The first objective of this study was to establish an international standard 20-item test system, which has not been established at all in Japan, and to present reference values in Japanese. Through this study, a 10-item test system, which is the basic complement test system of the international standard test, was established, and the results were disseminated at the annual meeting of the Japanese Society for Complement Research, The 10-item reference values were published as an original paper and also published in print (Otani et al., Hotai 2019). In addition, it is the only one in Japan to be certified by the International Society for Complementology as accurate, and researchers in Japan have been conducting clinical studies using these reference values, which have not only been reported at national conferences in 2022-3, but have also been used in international academic journals.

Academic Significance and Societal Importance of the Research Achievements

近年、抗補体薬が市販され、補体関連疾患に臨床応用がされた。しかしながら、本薬剤をどの時期に投与するか、その効果を如何に評価するかが、現時点では重要な課題と捉えられている。本研究によって、国際標準検査の基本的な補体検査系である10項目の検査体制は樹立され、国際補体学会の認証機関において日本で唯一の精度保証を受けている。本成果により、日本国内の研究者は、本基準値を用いた臨床研究を進め、国内学会でその研究報告がなされているばかりか、国際学会誌でもその成果が発表されている。

Report

(5 results)
  • 2023 Annual Research Report   Final Research Report ( PDF )
  • 2022 Annual Research Report
  • 2021 Annual Research Report
  • 2020 Annual Research Report
  • Research Products

    (12 results)

All 2024 2023 2022 2021 2020

All Journal Article (5 results) (of which Int'l Joint Research: 1 results,  Peer Reviewed: 5 results,  Open Access: 4 results) Presentation (4 results) (of which Invited: 4 results) Book (3 results)

  • [Journal Article] Immunological risk and complement genetic evaluations in early onset de novo thrombotic microangiopathy after living donor kidney transplantation: A Japanese multicenter registry2023

    • Author(s)
      Fujiyama N, Tasaki M, Harada H, Tsutahara K, Matsumoto A, Kamijo Y, Toyoda M, Iwami D, Inui M, Shirakawa H, Sugimura J, Saito M, Hotta K, Okumi M, Saito K, Watarai Y, Hidaka Y, Ohtani K, Inoue N, Wakamiya N, Habuchi T, Satoh S; Japanese Post-kidney Transplant TMA Support Team.
    • Journal Title

      Clinical and Experimental Nephrology

      Volume: 27 Issue: 12 Pages: 1010-1020

    • DOI

      10.1007/s10157-023-02391-5

    • Related Report
      2023 Annual Research Report 2022 Annual Research Report
    • Peer Reviewed / Open Access / Int'l Joint Research
  • [Journal Article] Complement biomarkers reflect the pathological status of neuromyelitis optica spectrum disorders2023

    • Author(s)
      Miyamoto K, Minamino M, Kuwahara M, Tsujimoto H, Ohtani K, Wakamiya N, Katayama KI, Inoue N, Ito H.
    • Journal Title

      Front Immunol

      Volume: 14 Pages: 109054-109054

    • DOI

      10.3389/fimmu.2023.1090548

    • Related Report
      2021 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Disseminated Gonococcal Infection in a Japanese Man with Complement 7 deficiency with compound heterozygous variants.2021

    • Author(s)
      Kageyama, M., Hagiya, H., Ueda, Y., Ohtani, K., Fukumori, Y., Inoue, N., Wakamiya, N., Yoneda, N., Kimura, K., Nagasawa, M., Nakagami, F., Nishi, I., Sugimoto, K., Rakugi H.
    • Journal Title

      Medicine

      Volume: 100 Issue: 13 Pages: e25265-e25265

    • DOI

      10.1097/md.0000000000025265

    • Related Report
      2020 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Early Elevation of Complement Factor Ba Is a Predictive Biomarker for Transplant-Associated Thrombotic Microangiopathy2021

    • Author(s)
      Okamura Hiroshi、Nakamae Hirohisa、Shindo Takero、Ohtani Katsuki、Hidaka Yoshihiko、Ohtsuka Yasufumi、Makuuchi Yosuke、Kuno Masatomo、Takakuwa Teruhito、Harada Naonori、Nishimoto Mitsutaka、Nakashima Yasuhiro、Koh Hideo、Hirose Asao、Nakamae Mika、Wakamiya Nobutaka、Hino Masayuki、Inoue Norimitsu
    • Journal Title

      Frontiers in Immunology

      Volume: 12 Pages: 695037

    • DOI

      10.3389/fimmu.2021.695037

    • NAID

      120007124372

    • URL

      https://ocu-omu.repo.nii.ac.jp/records/2019853

    • Related Report
      2020 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Lectin Purification and Analysis2020

    • Author(s)
      Ohtani K, Wakamiya N
    • Journal Title

      Springer Methods Mol Bio

      Volume: 2132 Pages: 99-109

    • Related Report
      2020 Annual Research Report
    • Peer Reviewed
  • [Presentation] 臨床に役立つ補体学のポイント2022

    • Author(s)
      若宮伸隆
    • Organizer
      第6回日本免疫不全・自己炎症学会総会
    • Related Report
      2021 Annual Research Report
    • Invited
  • [Presentation] 新規コレクチンの生態での役割について2022

    • Author(s)
      若宮伸隆
    • Organizer
      第58回日本補体学会
    • Related Report
      2021 Annual Research Report
    • Invited
  • [Presentation] 自己免疫疾患と補体2021

    • Author(s)
      若宮伸隆
    • Organizer
      第45回日本血液事業学会総会
    • Related Report
      2020 Annual Research Report
    • Invited
  • [Presentation] 血液製剤による各種疾患の治療と補体との関連について2020

    • Author(s)
      若宮伸隆
    • Organizer
      第66回日本輸血細胞治療学会
    • Related Report
      2020 Annual Research Report
    • Invited
  • [Book] 補体の活性化と制御-最近の進歩2024

    • Author(s)
      大谷克城, 若宮伸隆
    • Total Pages
      6
    • Publisher
      医学書院
    • Related Report
      2023 Annual Research Report 2022 Annual Research Report
  • [Book] 日本の補体検査の進展2022

    • Author(s)
      大谷克城, 若宮伸隆, 日髙義彦, 井上徳光
    • Total Pages
      6
    • Publisher
      日本臨床 = Japanese journal of clinical medicine
    • Related Report
      2021 Annual Research Report
  • [Book] 骨形成と補体: 3MC 症候群と Periodontal Ehlers-Danlos 症候群2022

    • Author(s)
      若宮伸隆, 大谷克城
    • Total Pages
      7
    • Publisher
      日本臨床 = Japanese journal of clinical medicine
    • Related Report
      2021 Annual Research Report

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Published: 2020-04-28   Modified: 2025-01-30  

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