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
  Purpose

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 Intervention Phase
Fecal Incontinence
Biological: ANT-SM
Phase 1

Study Type: Interventional
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 NLM:


Further study details as provided by Anterogen Co., Ltd.:

Primary Outcome Measures:
  • 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 ]

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

Arms Assigned Interventions
Experimental: ANT-SM
autologous adipose-derived stem cell
Biological: ANT-SM
autologous adipose-derived stem cell

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01011686

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Anterogen Co., Ltd.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01011686     History of Changes
Other Study ID Numbers: ANT-SM-101
Study First Received: November 10, 2009
Last Updated: March 8, 2011
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 30, 2014