title: A new method for treating fecal incontinence by implanting stem cells derived from human adipose tissue: preliminary findings of a randomized double-blind clinical trial.
abstract: Anal sphincter defects are a major cause of fecal incontinence causing negative effects on daily life, social interactions, and mental health. Because human adipose-derived stromal/stem cells (hADSCs) are easier and safer to access, secrete high levels of growth factor, and have the potential to differentiate into muscle cells, we investigated the ability of hADSCs to improve anal sphincter incontinence.
  
  
  
  The present randomized double-blind clinical trial was performed on patients with sphincter defects. They were categorized into a cell group (n = 9) and a control group (n = 9). Either 6 × 106hADSCs per 3 ml suspended in phosphate buffer saline (treatment) or 3 ml phosphate buffer saline (placebo) was injected. Two months after surgery, the Wexner score, endorectal sonography, and electromyography (EMG) results were recorded.
  
  
  
  Comparing Wexner scores in the cell group and the control group showed no significant difference. In our EMG and endorectal sonography analysis using ImageJ/Fiji 1.46 software, the ratio of the area occupied by the muscle to total area of the lesion showed a 7.91% increase in the cell group compared with the control group.
  
  
  
  The results of the current study show that injection of hADSCs during repair surgery for fecal incontinence may cause replacement of fibrous tissue, which acts as a mechanical support to muscle tissue with contractile function. This is a key point in treatment of fecal incontinence especially in the long term and may be a major step forward.
  
  
  
  Iranian Registry of Clinical Trials IRCT2016022826316N2 . Retrospectively registered 7 May 2016.
authors.affiliation: Colorectal Research Center, Iran University of Medical Sciences, Tehran, Iran.
authors.forename: Arash
authors.initials: A
authors.lastname: Sarveazad
authors.affiliation: Sydney Colorectal Associates, Prince of Wales Hospital, Randswick, NSW, Australia.
authors.forename: Graham L
authors.initials: GL
authors.lastname: Newstead
authors.affiliation: Colorectal Research Center, Iran University of Medical Sciences, Tehran, Iran.
authors.forename: Rezvan
authors.initials: R
authors.lastname: Mirzaei
authors.affiliation: Cellular and Molecular Research Center, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran.
authors.forename: Mohammad Taghi
authors.initials: MT
authors.lastname: Joghataei
authors.affiliation: Cellular and Molecular Research Center, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran.
authors.forename: Mehrdad
authors.initials: M
authors.lastname: Bakhtiari
authors.affiliation: Liver and Digestive Research Center, Kurdistan University of Medical Sciences, Sanandaj, Iran.
authors.forename: Asrin
authors.initials: A
authors.lastname: Babahajian
authors.affiliation: Colorectal Research Center, Iran University of Medical Sciences, Tehran, Iran. mahjoubi1167@gmail.com.
authors.forename: Bahar
authors.initials: B
authors.lastname: Mahjoubi
mesh_terms: D017667:Adipocytes / Q000166:cytology* / Q000502:physiology; D000273:Adipose Tissue / Q000166:cytology / Q000502:physiology; D000328:Adult; D000368:Aged; D001003:Anal Canal / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery; D002454:Cell Differentiation; D004311:Double-Blind Method; D004576:Electromyography; D005242:Fecal Incontinence / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D032342:Muscle Cells / Q000166:cytology* / Q000502:physiology; D013105:Sphincterotomy, Transduodenal / Q000379:methods; D033581:Stem Cell Transplantation; D013234:Stem Cells / Q000166:cytology* / Q000502:physiology; D014184:Transplantation, Homologous; D014463:Ultrasonography
keywords: Clinical trial; Fecal incontinence; Human; Stem cells derived from human adipose tissue