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

• Project/Area Number: 24591037
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: Circulatory organs internal medicine
• Research Institution: Niigata 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: ¥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.

Research Products

• [Journal Article] Hypocellularity and insufficient expression of angiogenic factors in implanted autologous bone marrow in patients with chronic critical limb ischernia (2012)
  • 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
  • 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
• [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
• [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
• [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
• [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
• [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/
• [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