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Investigation of Tissue Regeneration after Transplantation of Transcatheter Atrial Septal Closure Using Bioabsorbable Material

Research Project

Project/Area Number 20K09129
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Review Section Basic Section 55030:Cardiovascular surgery-related
Research InstitutionEhime University

Principal Investigator

Kurobe Hirotsugu  愛媛大学, 医学系研究科, 准教授 (30380083)

Co-Investigator(Kenkyū-buntansha) 平田 陽一郎  北里大学, 医学部, 准教授 (40447397)
坂上 倫久  愛媛大学, 医学系研究科, 講師(特定教員) (20709266)
Project Period (FY) 2020-04-01 – 2024-03-31
Project Status Completed (Fiscal Year 2023)
Budget Amount *help
¥4,290,000 (Direct Cost: ¥3,300,000、Indirect Cost: ¥990,000)
Fiscal Year 2022: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Fiscal Year 2021: ¥1,820,000 (Direct Cost: ¥1,400,000、Indirect Cost: ¥420,000)
Fiscal Year 2020: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Keywords生体分解性素材 / 心房中隔欠損症 / 医療デバイス / ASD / Occluder / Biodegradable Material / 生体吸収性 / 心房中隔欠損孔閉鎖デバイ / 動物実験 / 経カテーテル的 / 心臓血管外科 / 心房中隔欠損孔閉鎖デバイス / 生体吸収性素材 / 循環器科
Outline of Research at the Start

開発中の生体吸収性ASD閉鎖デバイスが移植された大動物から、移植後、3ヶ月、6ヶ月、1年を目処に安楽死させ、心臓や肝臓、脳等各臓器の摘出を行う。摘出臓器を用いて、組織学的評価(HE染色、EVG染色、免疫染色、石灰化所見の有無、内皮化の程度)を行い、
① デバイスの生体適合性・細胞障害性、② デバイス分解能、③ 自己組織再生、④ 梗塞等合併症等に関して評価し、その結果から、さらに生体に適合したデバイス改良を行う。また、医薬品医療機器総合機構(PMDA)等と相談を随時行いながら、‘Bench to Clinical’の臨床応用化に道筋をつける。

Outline of Final Research Achievements

Biodegradable atrial septal defect occluder devices were transcatheterally implanted in sheep and pigs, and subsequently, they were sacrificed over time. The explanted organs were evaluated using various staining techniques.
The results revealed satisfactory autologous organization at six months, one year, and one and a half years after implantation, with no indications of rejection or incomplete treatment. It was confirmed that the functionality of the device was intact. However, micricarcification was observed in some tissue areas, necessitating further evaluation to mitigate potential future issues.

Academic Significance and Societal Importance of the Research Achievements

試作中の生体分解性心房中隔欠損孔閉鎖デバイスを経カテーテル的に移植する実験を米国オハイオで羊で、福島県で実施した豚で実施し、動物を犠牲死させ、摘出臓器をHE染色、von Kossa染色、Azan染色などを駆使し染色・評価した。
その結果、移植後半年、一年、一年半の自己組織化は良好で、拒絶反応や治療の不完結性を疑う所見は認めず、本デバイスの実用化に近づく結果を得た。ただし、Micricarcificationを認たものの、治療完遂性には問題ないことも確認出来た。
生体吸収性素材を用いて治療デバイス実用化目処に近づいたことは、社会貢献に寄与でき、本実験により非常に有意義な結果を得た。

Report

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

    (10 results)

All 2023 2022 Other

All Int'l Joint Research (2 results) Journal Article (2 results) (of which Int'l Joint Research: 2 results,  Peer Reviewed: 2 results) Presentation (6 results) (of which Invited: 3 results)

  • [Int'l Joint Research] Nationwide Childrens Hospital/Ohio State University(米国)

    • Related Report
      2023 Annual Research Report
  • [Int'l Joint Research] オハイオ州立大学/Nationwide Children's Hospital(米国)

    • Related Report
      2021 Research-status Report
  • [Journal Article] Pre-clinical Evolution of a Novel Transcatheter Bioabsorbable ASD/PFO Occluder Device2023

    • Author(s)
      Matsuzaki Yuichi、Berman Darren P.、Kurobe Hirotsugu、Kelly John M.、Iwaki Ryuma、Blum Kevin、Toshihiro Shoji、Harrison Andrew、Cheatham John P.、Shinoka Toshiharu
    • Journal Title

      Pediatric Cardiology

      Volume: 43 Issue: 5 Pages: 986-994

    • DOI

      10.1007/s00246-021-02809-5

    • Related Report
      2023 Annual Research Report 2021 Research-status Report
    • Peer Reviewed / Int'l Joint Research
  • [Journal Article] 生体分解性素材を用いた医療デバイスの開発2023

    • Author(s)
      黒部裕嗣,新岡俊治,平田陽一郎,福西琢真 ,森谷友造, 倉田美恵,坂上倫久,檜垣高史,泉谷裕則
    • Journal Title

      愛媛医学

      Volume: 42 Pages: 119-126

    • Related Report
      2023 Annual Research Report
    • Peer Reviewed / Int'l Joint Research
  • [Presentation] 生体内分解性素材を用いた循環器治療用デバイス開発の現状2023

    • Author(s)
      黒部裕嗣
    • Organizer
      第53回日本心臓血管外科学会学術総会
    • Related Report
      2023 Annual Research Report
  • [Presentation] 低侵襲心臓手術 -現状と未来-2023

    • Author(s)
      黒部裕嗣
    • Organizer
      日本医工学治療学会第39回学術大会
    • Related Report
      2023 Annual Research Report
    • Invited
  • [Presentation] 循環器治療用デバイスへの生体吸収性素材の可能性2023

    • Author(s)
      黒部裕嗣
    • Organizer
      第60回日本人工臓器学会大会
    • Related Report
      2023 Annual Research Report
  • [Presentation] 生体内分解性素材を用いた循環器治療用デバイス開発の現状-ASD閉鎖デバイスでの取り組み-2023

    • Author(s)
      黒部裕嗣
    • Organizer
      第53回日本心臓血管外科学会
    • Related Report
      2022 Research-status Report
  • [Presentation] 循環器治療用デバイスへの生体吸収性素材の可能性2022

    • Author(s)
      黒部裕嗣
    • Organizer
      2022年 繊維学会秋季研究発表会
    • Related Report
      2022 Research-status Report
    • Invited
  • [Presentation] 循環器治療用デバイスへの生体吸収性素材の可能性2022

    • Author(s)
      黒部裕嗣
    • Organizer
      第60回日本人工臓器学会大会
    • Related Report
      2022 Research-status Report
    • Invited

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

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