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Development of autologous heart valves "biovalves" and their application to TAVI by combination of photomolding and in-body tissue architecture

Research Project

Project/Area Number 26293314
Research Category

Grant-in-Aid for Scientific Research (B)

Allocation TypePartial Multi-year Fund
Section一般
Research Field Cardiovascular surgery
Research InstitutionNational Cardiovascular Center Research Institute

Principal Investigator

Nakayama Yasuhide  国立研究開発法人国立循環器病研究センター, その他部局等, その他 (50250262)

Project Period (FY) 2014-04-01 – 2017-03-31
Project Status Completed (Fiscal Year 2016)
Budget Amount *help
¥15,990,000 (Direct Cost: ¥12,300,000、Indirect Cost: ¥3,690,000)
Fiscal Year 2016: ¥5,590,000 (Direct Cost: ¥4,300,000、Indirect Cost: ¥1,290,000)
Fiscal Year 2015: ¥5,330,000 (Direct Cost: ¥4,100,000、Indirect Cost: ¥1,230,000)
Fiscal Year 2014: ¥5,070,000 (Direct Cost: ¥3,900,000、Indirect Cost: ¥1,170,000)
Keywordsバイオバルブ / 心臓弁 / 再生医療 / 生体内組織形成術 / 移植・再生医療 / 外科 / 細胞・組織 / 生体機能利用 / バイオリアクター
Outline of Final Research Achievements

The Biovalve preparation molds could be produced rapidly by using a 3D printing machine. Upon 2- month goat subcutaneous embedding aortic or pulmonary valve-shaped Biovalves were obtained from completely autologous connective tissue with collagen and fibroblasts. The three leaflet tissues were seamlessly connected with the surrounding conduit tissue, and showed homogeneous wall thickness and excellent mechanical strength that was equivalent to or more than that of the human pericardium, with individual or regional differences. As an aortic valve, in vitro evaluation of Biovalve showed excellent valvular functions. In a goat model, postoperative echocardiography after surgical replacement of the biovalves with stents showed smooth movement of the leaflets with little regurgitation under systemic circulation. In all implantation studies, the luminal surface after implantation was very smooth and fully covered with thin neointima, including endothelial cells without thrombus formation.

Report

(4 results)
  • 2016 Annual Research Report   Final Research Report ( PDF )
  • 2015 Annual Research Report
  • 2014 Annual Research Report
  • Research Products

    (28 results)

All 2017 2016 2015 2014 2013 Other

All Journal Article (13 results) (of which Int'l Joint Research: 3 results,  Peer Reviewed: 12 results,  Acknowledgement Compliant: 1 results,  Open Access: 1 results) Presentation (13 results) (of which Int'l Joint Research: 7 results) Remarks (2 results)

  • [Journal Article] Development of a stent-biovalve with round-shaped leaflets: in vitro hydrodynamic evaluation for transcatheter pulmonary valve implantation (TPVI).2016

    • Author(s)
      Sumikura H, Nakayama Y, Ohnuma K, Takewa Y, Tatsumi E.
    • Journal Title

      J Artif Organs

      Volume: 19(4) Issue: 4 Pages: 357-363

    • DOI

      10.1007/s10047-016-0909-6

    • Related Report
      2016 Annual Research Report
    • Peer Reviewed / Int'l Joint Research
  • [Journal Article] Mechanical properties of human autologous tubular connective tissues(human biotubes) obtained from patients undergoing peritoneal dialysis2016

    • Author(s)
      Yasuhide Nakayama, Yoshiyuki Kaneko, Yoshiaki Takewa Y, Noriko Okumura
    • Journal Title

      JOURNAL OF BIOMEDICAL MATERIALS RESEARCH PART B: APPLIED MATERIALS

      Volume: 104 Issue: 7 Pages: 1-10

    • DOI

      10.1002/jbm.b.33495

    • Related Report
      2016 Annual Research Report
    • Peer Reviewed / Int'l Joint Research
  • [Journal Article] Preparation and characterization of directed, one-day-self-assembled millimeter-size spheroids of adipose-derived mesenchymal stem cells2016

    • Author(s)
      Ryosuke Iwai, Yasushi Nemoto, Yasuhide Nakayama
    • Journal Title

      J Biomed Mater Res Part A

      Volume: 104A Issue: 1 Pages: 305-312

    • DOI

      10.1002/jbm.a.35568

    • Related Report
      2016 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Patch tracheoplasty in body tissue engineering using collagenous connective tissue membranes (biosheets)2015

    • Author(s)
      K. Hoshi et al
    • Journal Title

      J Pediatr Surg

      Volume: 51(2) Issue: 2 Pages: 244-8

    • DOI

      10.1016/j.jpedsurg.2015.10.068

    • Related Report
      2016 Annual Research Report
    • Peer Reviewed
  • [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(4) Issue: 4 Pages: 382-6

    • DOI

      10.1007/s10047-015-0856-7

    • Related Report
      2015 Annual Research Report
    • Peer Reviewed / Int'l Joint Research
  • [Journal Article] In vitro hydrodynamic evaluation of a biovalve with stent (tubular leaflet type) for transcatheter pulmonary valve implantation2015

    • Author(s)
      Sumikura H, Nakayama Y, Ohnuma K, Kishimoto S, Takewa Y, Tatsumi E
    • Journal Title

      J Artif Organs

      Volume: 18(4) Issue: 4 Pages: 307-314

    • DOI

      10.1007/s10047-015-0851-z

    • Related Report
      2015 Annual Research Report
    • Peer Reviewed / Acknowledgement Compliant
  • [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(1) Issue: 1 Pages: 54-61

    • DOI

      10.1016/j.jvc.2014.12.003

    • Related Report
      2015 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Sutureless aortic valve replacement using a novel autologous tissue heart valve with stent (stent biovalve): proof of concept2015

    • 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(2) Issue: 2 Pages: 185-190

    • DOI

      10.1007/s10047-015-0817-1

    • Related Report
      2015 Annual Research Report 2014 Annual Research Report
    • 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(1) Issue: 1 Pages: 40-7

    • DOI

      10.1007/s10047-014-0793-x

    • Related Report
      2015 Annual Research Report 2014 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Development of Self-Expanding Valved Stents with Autologous Tubular Leaflet Tissues for Transcatheter Valve Implantation2015

    • Author(s)
      Funayama M, Sumikura H, Takewa Y, Tatsumi E, Nakayama Y
    • Journal Title

      J Artif Organ

      Volume: 未定

    • Related Report
      2014 Annual Research Report
  • [Journal Article] In-body tissue engineered aortic valve (Biovalve type VII) architecture based on 3D printer molding2014

    • Author(s)
      Nakayama Y, Takewa Y, Sumukura H, Yamanami M, Matsui Y, Oie T, Kishimoto Y, Arakawa M, Ohnuma K, Kanda K, Tatsumi E
    • Journal Title

      J Biomed Mater Res B Appl Biomater

      Volume: (in press) Issue: 1 Pages: 1-10

    • DOI

      10.1002/jbm.b.33186

    • Related Report
      2015 Annual Research Report 2014 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] In vitro evaluation of a novel autologous aortic valve (Biovalve) with a pulsatile circulation circuit2014

    • Author(s)
      Sumikura H, Nakayama Y, Ohmuma K, Takewa Y, Tastumi E
    • Journal Title

      Artif Organs

      Volume: (in press) Issue: 4 Pages: 282-9

    • DOI

      10.1111/aor.12173

    • Related Report
      2014 Annual Research Report
    • Peer Reviewed
  • [Journal Article] In-body tissue-engineered collagenous connective tissue membranes (BIOSHEETs) for potential corneal stromal substitution.2013

    • Author(s)
      Takiyama N, Uechi M, Nakayama Y, et. al.
    • Journal Title

      J Tissue Eng Regen Med.

      Volume: - Issue: 10 Pages: E518-E526

    • DOI

      10.1002/term.1859

    • Related Report
      2016 Annual Research Report
    • Peer Reviewed
  • [Presentation] 生体内組織形成術(IBTA)によるバイオバルブ開発20172017

    • Author(s)
      中山泰秀
    • Organizer
      第16回日本再生医療学会総会
    • Place of Presentation
      仙台
    • Year and Date
      2017-03-07
    • Related Report
      2016 Annual Research Report
  • [Presentation] Long-term Follow-up Results after Allogenic Implantation of In-body Tissue-engineered Heart Valves (Biovalves) as a Pulmonary Valve in a Goat Model2017

    • Author(s)
      Yasuhide Nakayama
    • Organizer
      Heart Valve Society Scientific Meeting 2016
    • Place of Presentation
      Monaco
    • Year and Date
      2017-03-02
    • Related Report
      2016 Annual Research Report
    • Int'l Joint Research
  • [Presentation] バイオバルブ心臓弁の長期移植評価と生きたグ ラフトとしての可能性の検討2016

    • Author(s)
      武輪 能明1)、中山泰秀、住倉博仁、飯塚慶、 秋山大地、片桐伸将、竹下大輔、小崎智史、 妙中義之、巽英介
    • Organizer
      第54回日本人工臓器学会大会
    • Place of Presentation
      米子
    • Year and Date
      2016-11-23
    • Related Report
      2016 Annual Research Report
  • [Presentation] In Body Tissue Engineering Approach for Autologous 3D Tissue Fabrication and Their Clinical Application2016

    • Author(s)
      Yasuhide Nakayama
    • Organizer
      Biofabrication 2016 Conference
    • Place of Presentation
      Winston-Salem
    • Year and Date
      2016-10-29
    • Related Report
      2016 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Type SC Biovalve Aortic Valve Based on In-Body Tissue Architecture (IBTA): Design, In Vivo Fabrication and Animal Implantation2016

    • Author(s)
      Yasuhide Nakayama, Yoshiaki Takewa Hirohito Sumikura, Eisuke Tatsumi
    • Organizer
      7th Biennial Heat Valve Biology and Tissue Engineering Meeting
    • Place of Presentation
      Hilton Head Island
    • Year and Date
      2016-10-12
    • Related Report
      2016 Annual Research Report
    • Int'l Joint Research
  • [Presentation] A Novel Autologous Heart Valve with Growth Potential2016

    • Author(s)
      Y. Takewa , Y. Nakayama, H. Sumikura, N. Naito, K. Iizuka, K. Kanda, E. Tatsumi
    • Organizer
      European Society for Cardiology
    • Place of Presentation
      Roma
    • Year and Date
      2016-08-27
    • Related Report
      2016 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Development of In Vivo, Tissue-‐Engineered, Autologous, 3D Heart Valvular Tissue, Type SC Biovalve with Excellent Mechanical ProperFes, Valvular FuncFons, and In Vivo Performance2015

    • 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
    • Related Report
      2015 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Funayama M, Furukoshi M, Moriwaki T, Nakayama Y2015

    • 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
    • Related Report
      2015 Annual Research Report
    • Int'l Joint Research
  • [Presentation] A tailor made valve surgery with a novel autologous bioprosthesis2015

    • 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
    • Related Report
      2015 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Development of a novel autologous heart valve (biovalve stent) for transcatheter implantation2014

    • Author(s)
      Takewa Y, Nakayama Y, Kishimoto S, Date K, Sumikura H, Kanda K, Tanaka T, Tatsumi E
    • Organizer
      XLI Annual ESAO Congress
    • Place of Presentation
      Roma
    • Year and Date
      2014-09-17 – 2014-09-20
    • Related Report
      2014 Annual Research Report
  • [Presentation] Key factors to develop histogenesis in a novel autologous heart valve implantation2014

    • Author(s)
      Takewa Y, Nakayama Y, Sumikura H, Kishimoto S, Date K, Wieloch R, Kanda k, tajikawa T, Tanaka T, Tatsumi E
    • Organizer
      European Society for Cardiology (ESC) Congress 2014
    • Place of Presentation
      Barcelona
    • Year and Date
      2014-08-30 – 2014-09-03
    • Related Report
      2014 Annual Research Report
  • [Presentation] 3D printer-based molding for the preparation of biovalve family in in-body tissue architecture technology2014

    • Author(s)
      Nakayama Y, Takewa Y, Uechi M, Kanda K, Moriwaki T, Oie T, Tanaka T, Sugiura H
    • Organizer
      Heart Valve Society of America, Valves in the Heart of the Big Apple VIII
    • Place of Presentation
      New York
    • Year and Date
      2014-05-08 – 2014-05-10
    • Related Report
      2014 Annual Research Report
  • [Presentation] Preparation of an autologous heart valve with a stent (stent-biovale) using the stent eversion method2014

    • Author(s)
      Nakayama Y, Mizuno T, Takewa Y, Sumikura H, Ohmuma K, Moriwaki T, Yamanami M, Oie T, Tatsumi E, Kanda K
    • Organizer
      International Congress of the European Society for Cardiovascular and Endovascular Surgery
    • Place of Presentation
      Nice
    • Year and Date
      2014-04-27
    • Related Report
      2014 Annual Research Report
  • [Remarks] 卓越する国循

    • URL

      http://www.ncvc.go.jp/about/excellence/07.html

    • Related Report
      2016 Annual Research Report
  • [Remarks] 生体再生技術研究会

    • URL

      http://ibta.jp

    • Related Report
      2014 Annual Research Report

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Published: 2014-04-04   Modified: 2018-03-22  

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