| Project/Area Number |
16K11046
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Research Field |
Urology
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| Research Institution | Nagoya University |
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Principal Investigator |
GOTOH Momokazu 名古屋大学, 医学系研究科, 教授 (10186900)
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| Co-Investigator(Kenkyū-buntansha) |
山本 徳則 名古屋大学, 医学系研究科, 特任教授 (20182636)
舟橋 康人 名古屋大学, 医学部附属病院, 病院講師 (70534824)
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| Project Period (FY) |
2016-04-01 – 2019-03-31
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| Project Status |
Completed (Fiscal Year 2018)
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| Budget Amount *help |
¥4,420,000 (Direct Cost: ¥3,400,000、Indirect Cost: ¥1,020,000)
Fiscal Year 2018: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Fiscal Year 2017: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2016: ¥1,950,000 (Direct Cost: ¥1,500,000、Indirect Cost: ¥450,000)
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| Keywords | 再生治療 / 脂肪由来再生細胞 / 尿失禁 / 尿道括約筋障害 / 括約筋障害 / 再生医学 |
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| Outline of Final Research Achievements |
No minimally invasive surgical treatment is available for male stress urinary incontinence (SUI), and development of minimally invasive regenerative treatment has been expected. We have been conducting a prospective,multicenter investigator-initiated clinical trial of periurethral injection of non-cultured autologous adipose-derived regenerative cells for male SUI with an approval of the PMDA and completed an enrollment of all 45 patients by 2018. On the other hand, PMDA requested to investigate the mechanism of action of the treatment and the safety of ADRCs, in terms of their effects on prostate cancer cells, which were clarified in the present study. The outcome of the present study should accelerate an approval by PMDA and coverage of health insurance of this world-first regenerative treatment for male SUI.
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| Academic Significance and Societal Importance of the Research Achievements |
男性腹圧性尿失禁に対しては、低侵襲外科的治療がなく、低侵襲再生治療の開発が期待されている。我々はPMDAとの対面助言を実施し、男性腹圧性尿失禁を対象に自己非培養ADRCsの経尿道的傍尿道注入治療の多施設共同医師主導治験を実施中で、2018年度までに45例の組み入れを終了し、現在薬事承認・保険収載を目指している。他方、PMDAから保険収載にあたりADRCs作用メカニズムの解明と前立腺癌症例に投与する際の安全性の基礎的検討を求められており、本研究で得られた成果により、本治療の薬事承認、保険収載が早期に実現されることが期待される。
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