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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01011686
Recruitment Status : Terminated (Few subject enrolled)
First Posted : November 11, 2009
Last Update Posted : March 10, 2011
Information provided by:
Anterogen Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fecal Incontinence Biological: ANT-SM Phase 1

Study Type : Interventional  (Clinical Trial)
Official Title: A Phase I Clinical Study of ANT-SM (Autologous Cultured Adipose-derived Stem Cell) for the Treatment of Fecal Incontinence to Evaluate Safety

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: ANT-SM
autologous adipose-derived stem cell
Biological: ANT-SM
autologous adipose-derived stem cell

Primary Outcome Measures :
  1. Efficacy: Wexner's score evaluation
  2. Safety: Clinically measured abnormality of laboratory tests and adverse events

Secondary Outcome Measures :
  1. Anorectal manometry and endorectal ultrasound at week 4

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01011686

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Anterogen Co., Ltd. Identifier: NCT01011686     History of Changes
Other Study ID Numbers: ANT-SM-101
First Posted: November 11, 2009    Key Record Dates
Last Update Posted: March 10, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases