Design of a single-arm clinical trial of regenerative therapy by periurethral injection of adipose-derived regenerative cells for male stress urinary incontinence in Japan: the ADRESU study protocol
作者: Shinobu ShimizuTokunori YamamotoShinobu NakayamaAkihiro HirakawaYachiyo KuwatsukaYasuhito FunahashiYoshihisa MatsukawaKeisuke TakanariKazuhiro ToriyamaYuzuru KameiKazutaka NarimotoTomonori YamanishiOsamu IshizukaMasaaki MizunoMomokazu Gotoh
作者单位: 1Nagoya University Hospital
2Nagoya University Graduate School of Medicine
3Department of Clinical Research Management, Clinical Research Center, National Hospital Organization Nagoya Medical Center
4The University of Tokyo
5Nagoya City University Hospital
6Kanazawa University Graduate School of Medical Sciences
7Continence Center, Dokkyo Medical University
8Shinshu University School of Medicine
刊名: BMC Urology, 2017, Vol.17 (1)
来源数据库: Springer Nature Journal
DOI: 10.1186/s12894-017-0282-7
关键词: Stress urinary incontinenceLower urinary tract symptomsRegenerative medicineCell therapyProstatectomyAdipose-derived regenerative cells
原始语种摘要: Male stress urinary incontinence is a prevalent condition after radical prostatectomy. While the standard recommendation for the management of urine leakage is pelvic floor muscle training, its efficacy is still unsatisfactory. Therefore, we have focused on regenerative therapy, which consists of administering a periurethral injection of autologous regenerative cells from adipose tissue, separated using the Celution® system. Based on an interim data analysis of our exploratory study, we confirmed the efficacy and acceptable safety profile of this treatment. Accordingly, we began discussions with Japanese regulatory authorities regarding the development of this therapy in Japan. The Ministry of Health, Labour and Welfare suggested that we implement a clinical trial of a new medical device...
全文获取路径: Springer Nature  (合作)
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影响因子:1.694 (2012)

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关键词翻译
关键词翻译
  • regenerative 再生放大
  • urinary 尿的
  • incontinence 失禁
  • periurethral 尿道周的
  • adipose 脂肪的
  • trial 试验
  • cells 麻风细胞
  • therapy 治疗
  • derived 导生的
  • stress 应力