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

Primary Purpose

Fecal Incontinence

Status
Terminated
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ANT-SM
Sponsored by
Anterogen Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Fecal Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ANT-SM

Arm Description

autologous adipose-derived stem cell

Outcomes

Primary Outcome Measures

Efficacy: Wexner's score evaluation
Safety: Clinically measured abnormality of laboratory tests and adverse events

Secondary Outcome Measures

Anorectal manometry and endorectal ultrasound at week 4

Full Information

First Posted
November 10, 2009
Last Updated
March 8, 2011
Sponsor
Anterogen Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01011686
Brief Title
Safety Study of Autologous Cultured Adipose -Derived Stem Cells for the Fecal Incontinence
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Terminated
Why Stopped
Few subject enrolled
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Anterogen Co., Ltd.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence

7. Study Design

Study Phase
Phase 1

8. Arms, Groups, and Interventions

Arm Title
ANT-SM
Arm Type
Experimental
Arm Description
autologous adipose-derived stem cell
Intervention Type
Biological
Intervention Name(s)
ANT-SM
Intervention Description
autologous adipose-derived stem cell
Primary Outcome Measure Information:
Title
Efficacy: Wexner's score evaluation
Title
Safety: Clinically measured abnormality of laboratory tests and adverse events
Secondary Outcome Measure Information:
Title
Anorectal manometry and endorectal ultrasound at week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

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

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