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Treatment of faecal incontinence using allogeneic-adipose-derived mesenchymal stem cells: a study protocol for a pilot randomised controlled trial.

 Eun Jung Park  ;  Jeonghyun Kang  ;  Seung Hyuk Baik 
 BMJ OPEN, Vol.6(2) : 010450, 2016 
Journal Title
Issue Date
Adipose Tissue ; Fecal Incontinence/therapy* ; Humans ; Mesenchymal Stem Cell Transplantation* ; Mesenchymal Stromal Cells ; Pilot Projects ; Prospective Studies ; Research Design* ; Single-Blind Method ; Transplantation, Homologous ; Treatment Outcome
adipose-derived mesenchymal stem cell ; fecal incontinence ; mesenchymal stem cell ; stem cell
INTRODUCTION: Faecal incontinence is a distressing condition with recurrent uncontrolled passage of faecal material. Although faecal incontinence may cause psychological depression and social isolation, previous treatments have been limited. Recently, regenerative treatment has been developed using mesenchymal stem cells. Especially, there are possibilities that adipose-tissue-derived stem cells can be effective to treat a degenerated anal sphincter that is causing faecal incontinence. Therefore, this study aimed to investigate the safety and efficacy of using allogeneic-adipose-derived mesenchymal stem cells in the treatment of the anal sphincter of patients with faecal incontinence. METHODS AND ANALYSIS: This study is a randomised, prospective, dose escalation, placebo-controlled, single-blinded, single-centre trial with two parallel groups. The safety test is performed by an injection of allogeneic-adipose-derived mesenchymal stem cells (ALLO-ASCs) into the anal sphincter with dose escalation (3 × 10(7), 6 × 10(7) and 9 × 10(7) cells, sequentially). After confirming the safety of the stem cells, an efficacy test is performed by this dose in the experimental group. The experimental group will receive ALLO-ASCs mixed with fibrin glue into the anal sphincter, and the placebo group will receive 0.9% normal saline injection mixed with fibrin glue. The primary end point is to assess the safety of ALLO-ASCs after the injection into the anal sphincter, and the secondary end point is to compare the efficacy of ALLO-ASC injection with fibrin glue in patients with faecal incontinence. ETHICS AND DISSEMINATION: The study protocol was approved by the Ministry of Food and Drug Safety and the Ministry of Health & Welfare, in the Republic of Korea. The informed consent form was approved by the institutional review board of Gangnam Severance Hospital (IRB approval number 3-2014-0271). Dissemination of the results will be presented at a conference and in peer-reviewed publications.
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1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
Yonsei Authors
Kang, Jeonghyun(강정현) ORCID logo https://orcid.org/0000-0001-7311-6053
Park, Eun Jung(박은정) ORCID logo https://orcid.org/0000-0002-4559-2690
Baik, Seung Hyuk(백승혁) ORCID logo https://orcid.org/0000-0003-4183-2332
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