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TerminatedNCT01011686Updated Mar 10, 2011

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

A Phase 1 interventional study of ANT-SM in Fecal Incontinence, sponsored by Anterogen Co., Ltd.. Terminated at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-03-10.

Sponsored by Anterogen Co., Ltd. · Phase 1 and Interventional

Why this study was terminated
Few subject enrolled
Phase
Phase 1
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Fecal Incontinence

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03

In context

Fecal Incontinence

312 studies on the registry are indexed under Fecal Incontinence; 57 are open to participants now.

Browse Fecal Incontinence studies →

Lead sponsor

Anterogen Co., Ltd. is the lead sponsor of 30 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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)
05

Study design

Phase
Phase 1

Study arms

  • Experimental
    ANT-SM

    autologous adipose-derived stem cell

    Biological: ANT-SM

Interventions

  • BiologicalANT-SM

    autologous adipose-derived stem cell

06

What researchers measure

Primary outcomes

  1. Efficacy: Wexner's score evaluation

  2. Safety: Clinically measured abnormality of laboratory tests and adverse events

Secondary outcomes

  1. Anorectal manometry and endorectal ultrasound at week 4

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01011686
Lead sponsor
Anterogen Co., Ltd.
First posted
Nov 11, 2009
Last update
Mar 10, 2011
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

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