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

This study has been terminated.
(Few subject enrolled)
Sponsor:
Information provided by:
Anterogen Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01011686
First received: November 10, 2009
Last updated: March 8, 2011
Last verified: March 2011

November 10, 2009
March 8, 2011
Not Provided
Not Provided
  • Efficacy: Wexner's score evaluation [ Designated as safety issue: Yes ]
  • Safety: Clinically measured abnormality of laboratory tests and adverse events [ Designated as safety issue: Yes ]
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
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Not Provided
Fecal Incontinence
Biological: ANT-SM
autologous adipose-derived stem cell
Experimental: ANT-SM
autologous adipose-derived stem cell
Intervention: Biological: ANT-SM
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
Not Provided
Not Provided
Not Provided

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01011686
ANT-SM-101
Not Provided
Not Provided
Anterogen Co., Ltd.
Not Provided
Not Provided
Anterogen Co., Ltd.
March 2011

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