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Safety Study of Autologous Cultured Adipose -Derived Stem Cells for the Fecal Incontinence

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ClinicalTrials.gov Identifier: NCT01011686
Recruitment Status : Terminated (Few subject enrolled)
First Posted : November 11, 2009
Last Update Posted : March 10, 2011
Information provided by:

November 10, 2009
November 11, 2009
March 10, 2011
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  • Efficacy: Wexner's score evaluation
  • Safety: Clinically measured abnormality of laboratory tests and adverse events
Same as current
Complete list of historical versions of study NCT01011686 on ClinicalTrials.gov Archive Site
Anorectal manometry and endorectal ultrasound at week 4
Same as current
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Safety Study of Autologous Cultured Adipose -Derived Stem Cells for the Fecal Incontinence
A Phase I Clinical Study of ANT-SM (Autologous Cultured Adipose-derived Stem Cell) for the Treatment of Fecal Incontinence to Evaluate Safety
Fecal incontinence affects 18.4% adults in the community and greatly impacts quality of life. There's a problem like inconvenience, pain or allergic response in many therapeutic methods such as a surgical operation or material injection. ANT-SM is autologous adipose-derived stem cell, and so, expect of no immune responses. In this study, patients are given injection of ANT-AM in anal sphincter and followed for 4 weeks to test the safety.
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Phase 1
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Fecal Incontinence
Biological: ANT-SM
autologous adipose-derived stem cell
Experimental: ANT-SM
autologous adipose-derived stem cell
Intervention: Biological: ANT-SM
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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Inclusion Criteria:

  • Older than 18 years
  • Wexner's fecal incontinence score > or egal 5
  • patient who has fecal incontinence for more than 6 months
  • Continuity of anal sphincter at endorectal ultrasound and abnormality of anal function at anorectal manometry
  • negative for urine beta-HCG for woman of childbearing age
  • agreement to participate, with signed informed-consent

Exclusion Criteria:

  • Anorectal surgery within the last 6 months prior to the study
  • patient who is allergy to bovine-derived materials and an anesthetic
  • patients with a diagnosis of auto immune disease
  • Diagnosis of HBV, HCV, HIV and other infectious disease
  • Patients with a diagnosis of active Tuberculosis
  • Patient is pregnant or breast-feeding
  • Women within 6 months post partum
  • Patient who is unwilling to use an "effective" method of contraception during the study
  • Patients with a diagnosis of Inflammatory Bowel Disease
  • Patient who has a clinically relevant history of abuse of alcohol or drugs
  • Insufficient adipose tissue for manufacturing of ANT-SM
  • Patient whom investigator consider is not suitable in this study
  • Patients have history of surgery for malignant cancer in the past 5 years
  • Patient who has to undergo ano-rectal surgery
  • Patient who has a history of artificial anal sphincter surgery
  • Patient who has taken cytotoxic drugs within the last 30 days
  • Patient whom investigator consider is not suitable in this study reasons for severe ano-rectal disease, severe constipation, fistula, rectal prolapsed or neurological diseases (spinal cord injury, multiple sclerosis, Parkinson's disease)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
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Anterogen Co., Ltd.
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Anterogen Co., Ltd.
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP