光造形と体内造形の融合による自家組織バイオバルブ心臓弁の開発とTAVIへの展開

2015 Fiscal Year Annual Research Report

• Project/Area Number: 26293314
• Research Institution: National Cardiovascular Center Research Institute
• Principal Investigator: 中山 泰秀 国立研究開発法人国立循環器病研究センター, 研究所, 室長 (50250262)
• Project Period (FY): 2014-04-01 – 2017-03-31
• Keywords: 移植・再生医療

Outline of Annual Research Achievements

研究項目１）鋳型基材の生物学的安全性評価
鋳型基材として使用しているシリコーン樹脂と3Dプリンター造形物のアクリル樹脂に関して、細胞レベルでの毒性試験を行い問題がないことを確かめた。また、ビーグル犬を用いた動物皮下への埋め込み試験において、炎症などがないことを確かめることができ、臨床評価に向けた生物学的安全性を有していると判断できた。
研究項目２）試作品の生体外機能耐久性試験
ステント付バイオバルブについて、生体外模擬回路を用いて拍動流下での機能試験を実施し、心臓弁として良好な機能を有していることを確認した。
研究項目３）バイオバルブの肺動脈弁移植機能評価
ヤギの皮下に鋳型基材を埋め込むことで、２か月後にバイオバルブ心臓弁を得ることができた。これを心停止下でヤギの肺動脈弁置換をすることに成功した。半年以上の生存を良好な弁機能を維持しながら継続している。

Current Status of Research Progress

2: Research has progressed on the whole more than it was originally planned.

Reason

当初の計画に全て着手でき、良好な結果が得られれいる。

Strategy for Future Research Activity

特に変更の必要はない。

Causes of Carryover

予定していた研究の一部が年度をまたぎ、請求が次年度となったため。

Expenditure Plan for Carryover Budget

請求書は既に届いており、次年度の様式が確定次第支払いを行う。

Research Products

• [Journal Article] Development of an in vivo tissue-engineered valved conduit (type S biovalve) using a slitted mold (2015)
  • Author(s): Funayama M, Furukoshi M, Moriwaki T, Nakayama Y
  • Journal Title: J Artif Organs Volume: 18 Pages: 382-386
  • DOI: 10.1007/s10047-015-0856-7
  • Peer Reviewed
• [Journal Article] In vitro hydrodynamic evaluation of a biovalve with stent (tubular leaflet type) for transcatheter pulmonary valve implantation (2015)
  • Author(s): Sumikura H, Nakayama Y, Ohnuma K, Kishimoto S, Takewa Y, Tatsumi E
  • Journal Title: J Artif Organs Volume: 18 Pages: 307-314
  • DOI: 10.1007/s10047-015-0851-z
  • Peer Reviewed
• [Journal Article] Successful implantation of autologous valved conduits with self-expanding stent (stent-biovalve) within the pulmonary artery in beagle dogs (2015)
  • Author(s): Funayama M, Matsui Y, Tajikawa T, Sasagawa T, Saito Y, Sagishima S, Mizuno T, Mizuno M, Harada K, Uchida S, Shinoda A, Iwai R, Nakayama Y, Uechi M
  • Journal Title: J Vet Cardiol Volume: 17 Pages: 54-61
  • DOI: 10.1016/j.jvc.2014.12.003
  • Peer Reviewed
• [Journal Article] Sutureless aortic valve replacement using a novel autologous tissue heart valve with stent (stent biovalve): proof of concept (2015)
  • Author(s): Kishimoto S, Takewa Y, Nakayama Y, Date K, Sumikura H, Moriwaki T, Nishimura M, Tatsumi E
  • Journal Title: J Artif Organs Volume: 18 Pages: 185-190
  • DOI: 10.1007/s10047-015-0817-1
  • Peer Reviewed
• [Journal Article] In situ observation and enhancement of leaflet tissue formation in bioprosthetic "biovalve" (2015)
  • Author(s): Funayama M, Takewa Y, Oie T, Matsui Y, Tatsumi E, Nakayama Y
  • Journal Title: J Artif Organs Volume: 18 Pages: 40-47
  • DOI: 10.1007/s10047-014-0793-x
  • Peer Reviewed
• [Journal Article] In-body tissue-engineered aortic valve (Biovalve type VII) architecture based on 3D printer molding (2015)
  • Author(s): Nakayama Y, Takewa Y, Sumikura H, Yamanami M, Matsui Y, Oie T, Kishimoto Y, Arakawa M, Ohmuma K, Tajikawa T, Kanda K, Tatsumi E
  • Journal Title: J Biomed Mater Res B Appl Biomater Volume: 103 Pages: 1-11
  • DOI: 10.1002/jbm.b.33186
  • Peer Reviewed
• [Presentation] Development of In Vivo, Tissue-‐Engineered, Autologous, 3D Heart Valvular Tissue, Type SC Biovalve with Excellent Mechanical ProperFes, Valvular FuncFons, and In Vivo Performance (2015)
  • Author(s): Nakayama Y, Talewa Y, Moriwaki T, Sumikura H, Funayama M, Furukoshi M, Tatsumi E, Miyamoto S, Okamoto K.
  • Organizer: American Heart Association Scientific Sesson 2015
  • Place of Presentation: Orlando, USA
  • Year and Date: 2015-11-07 – 2015-11-11
  • Int'l Joint Research
• [Presentation] Funayama M, Furukoshi M, Moriwaki T, Nakayama Y (2015)
  • Author(s): In vivo tissue-engineered, autologous, valved conduits “Biovalves” with robust wall tissues
  • Organizer: European Society of Cardiology
  • Place of Presentation: London, United Kingdom
  • Year and Date: 2015-08-29 – 2015-09-02
  • Int'l Joint Research
• [Presentation] A tailor made valve surgery with a novel autologous bioprosthesis (2015)
  • Author(s): Y. Takewa , Y. Nakayama , H. Sumikura , N. Naito , K. Kanda , T. Tajikawa , T. Tanaka , E. Tatsumi
  • Organizer: European Society of Cardiology
  • Place of Presentation: London, United Kingdom
  • Year and Date: 2015-08-29 – 2015-09-02
  • Int'l Joint Research