title: Pre-clinical efficacy and safety evaluation of human amniotic fluid-derived stem cell injection in a mouse model of urinary incontinence.
abstract: OBJECTIVE
  Stem cell-based therapies represent new promises for the treatment of urinary incontinence. This study was performed to assess optimized cell passage number, cell dose, therapeutic efficacy, feasibility, toxicity, and cell trafficking for the first step of the pre-clinical evaluation of human amniotic fluid stem cell (hAFSC) therapy in a urinary incontinence animal model.
  
  
  METHODS
  The proper cell passage number was analyzed with hAFSCs at passages 4, 6, and 8 at week 2. The cell dose optimization included 1×10⁴, 1×10⁵, and 1×10⁶ cells at week 2. The in vivo cell toxicity was performed with 0.25×10⁶, 0.5×10⁶, and 1×10⁶ cells at weeks 2 and 4. Cell tracking was performed with 1×10⁶ cells at weeks 2 and 4.
  
  
  RESULTS
  The selected optimal cell passage number was smaller than 6, and the optimal cell dose was 1×10⁶ for the mouse model. In our pre-clinical study, hAFSC-injected animals showed normal values for several parameters. Moreover, the injected cells were found to be non-toxic and non-tumorigenic. Furthermore, the injected hAFSCs were rarely identified by in vivo cell trafficking in the target organs at week 2.
  
  
  CONCLUSIONS
  This study demonstrates for the first time the pre-clinical efficacy and safety of hAFSC injection in the urinary incontinence animal model and provides a basis for future clinical applications.
authors.affiliation: Department of Urology, School of Medicine, Kyungpook National University, Daegu, Korea.
authors.forename: Jae Young
authors.initials: JY
authors.lastname: Choi
authors.affiliation: Joint Institute for Regenerative Medicine, Kyungpook National University Hospital, Daegu, Korea.
authors.forename: So Young
authors.initials: SY
authors.lastname: Chun
authors.affiliation: Department of Urology, School of Medicine, Kyungpook National University, Daegu, Korea.
authors.forename: Bum Soo
authors.initials: BS
authors.lastname: Kim
authors.affiliation: Department of Urology, School of Medicine, Kyungpook National University, Daegu, Korea.
authors.forename: Hyun Tae
authors.initials: HT
authors.lastname: Kim
authors.affiliation: Department of Urology, School of Medicine, Kyungpook National University, Daegu, Korea.
authors.forename: Eun Sang
authors.initials: ES
authors.lastname: Yoo
authors.affiliation: Joint Institute for Regenerative Medicine, Kyungpook National University Hospital, Daegu, Korea.
authors.forename: Yun-Hee
authors.initials: YH
authors.lastname: Shon
authors.affiliation: Joint Institute for Regenerative Medicine, Kyungpook National University Hospital, Daegu, Korea.
authors.forename: Jeong Ok
authors.initials: JO
authors.lastname: Lim
authors.affiliation: Department of Urology, College of Medicine, Chungbuk National University, Cheongju, Korea.
authors.forename: Seok Joong
authors.initials: SJ
authors.lastname: Yun
authors.affiliation: Department of Urology, College of Medicine, Yeungnam University, Daegu, Korea.
authors.forename: Phil Hyun
authors.initials: PH
authors.lastname: Song
authors.affiliation: Department of Urology, School of Medicine, Kyungpook National University, Daegu, Korea.
authors.forename: Sung Kwang
authors.initials: SK
authors.lastname: Chung
authors.affiliation: Joint Institute for Regenerative Medicine, Kyungpook National University Hospital, Daegu, Korea.; Wake Forest Institute for Regenerative Medicine, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
authors.forename: James J
authors.initials: JJ
authors.lastname: Yoo
authors.affiliation: Department of Urology, School of Medicine, Kyungpook National University, Daegu, Korea.; Joint Institute for Regenerative Medicine, Kyungpook National University Hospital, Daegu, Korea. tgkwon@knu.ac.kr.
authors.forename: Tae Gyun
authors.initials: TG
authors.lastname: Kwon
mesh_terms: D000653:Amniotic Fluid / Q000166:cytology*; D000818:Animals; D002465:Cell Movement; D004195:Disease Models, Animal; D006801:Humans; D007267:Injections; D051379:Mice; D033581:Stem Cell Transplantation / Q000379:methods*; D013234:Stem Cells / Q000166:cytology*; D016896:Treatment Outcome; D014549:Urinary Incontinence / Q000628:therapy*
keywords: Preclinical evaluation; amniotic fluid; stem cells; urinary incontinence
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