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Long -term outcome of Ex Vivo Expanded Erythroblast-Transplantation for patient with critical limb ischemia

Research Project

Project/Area Number 24591037
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field Circulatory organs internal medicine
Research InstitutionNiigata University

Principal Investigator

OZAWA Takuya  新潟大学, 医歯学系, 助教 (70467075)

Co-Investigator(Kenkyū-buntansha) TOBA Ken  新潟大学, 医歯学総合病院, 講師 (60313540)
HANAWA Haruo  新潟大学, 医歯学系, 准教授 (40282983)
ODA Masato  新潟大学, 医歯学総合病院, 医員 (60572724)
YANAGAWA Takao  新潟大学, 医歯学総合病院, 特任助教 (10625586)
MORIYAMA Masato  新潟大学, 医歯学系, 助教 (30598131)
MASUKO Masayoshi  新潟大学, 医歯学総合病院, 准教授 (70397115)
SUDA Masayoshi  新潟大学, 医歯学総合病院, 医員 (70714509)
Project Period (FY) 2012-04-01 – 2015-03-31
Project Status Completed (Fiscal Year 2014)
Budget Amount *help
¥5,460,000 (Direct Cost: ¥4,200,000、Indirect Cost: ¥1,260,000)
Fiscal Year 2014: ¥1,040,000 (Direct Cost: ¥800,000、Indirect Cost: ¥240,000)
Fiscal Year 2013: ¥2,210,000 (Direct Cost: ¥1,700,000、Indirect Cost: ¥510,000)
Fiscal Year 2012: ¥2,210,000 (Direct Cost: ¥1,700,000、Indirect Cost: ¥510,000)
Keywords臨床心血管病態学 / 血管再生 / 赤芽球 / 細胞療法 / 体外増幅 / 細胞移植 / 血管新生治療 / 体外培養
Outline of Final Research Achievements

We investigated the efficacy of a novel cell therapy by implantation of ex vivo expanded immature erythroblasts cultured from hematopoietic stem/precursor cells. 13 patients with severe chronic limb ischemia accompanied by peripheral artery disease, Burger's disease or collagen arteritis were enrolled in a pilot clinical trial of the novel cell therapy by transplantation of ex-vivo expanded immature erythroid cells (EVEETA). In the clinical trial, most clinical symptoms such as rest pain and skin ulcers improved in 4 weeks, and did not recur in the one-year follow-up. A small amount of bone marrow (mean amount, 71.2 ± 20.1 mL) was collected from the patients under local anesthesia. After 14 days of culture, the number of erythroblasts increased to enough level for in vivo angiogenesis therapy (64.5 ± 41.3 times from baseline). No adverse events were observed in any of the patients.

Report

(4 results)
  • 2014 Annual Research Report   Final Research Report ( PDF )
  • 2013 Research-status Report
  • 2012 Research-status Report
  • Research Products

    (8 results)

All 2013 2012 Other

All Journal Article (1 results) (of which Peer Reviewed: 1 results) Book (1 results) Remarks (6 results)

  • [Journal Article] Hypocellularity and insufficient expression of angiogenic factors in implanted autologous bone marrow in patients with chronic critical limb ischernia2012

    • Author(s)
      Oda M, Toba K, Kato K, Ozawa T, 他
    • Journal Title

      Heart Vessels

      Volume: 27 Issue: 1 Pages: 38-45

    • DOI

      10.1007/s00380-011-0125-5

    • Related Report
      2012 Research-status Report
    • Peer Reviewed
  • [Book] 再生医療における臨床研究と製品開発2013

    • Author(s)
      小澤拓也 南野徹
    • Total Pages
      577
    • Publisher
      (株)技術情報協会
    • Related Report
      2013 Research-status Report
  • [Remarks] 新潟大学医歯学総合病院 循環器内科

    • URL

      http://www.med.niigata-u.ac.jp/car/research_ischemia.html

    • Related Report
      2014 Annual Research Report
  • [Remarks] 新潟大学医歯学総合病院 生命科学医療センター

    • URL

      http://bmrctr.jp/saisei/project/project2

    • Related Report
      2014 Annual Research Report
  • [Remarks] 新潟大学医歯学総合病院 循環器内科

    • URL

      http://www.med.niigata-u.ac.jp/car/research_ischemia.html

    • Related Report
      2013 Research-status Report
  • [Remarks] 新潟大学医歯学総合病院 生命科学医療センター

    • URL

      http://bmrctr.jp/saisei/project/project2

    • Related Report
      2013 Research-status Report
  • [Remarks] 新潟大学大学院医歯学総合研究科循環器内科学

    • URL

      http://www.med.niigata-u.ac.jp/car/

    • Related Report
      2012 Research-status Report
  • [Remarks] 新潟大学医歯学総合病院 生命科学医療センター

    • URL

      http://211.125.90.51/saisei/public/public3

    • Related Report
      2012 Research-status Report

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Published: 2013-05-31   Modified: 2019-07-29  

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