- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01011686
Safety Study of Autologous Cultured Adipose -Derived Stem Cells for the Fecal Incontinence
March 8, 2011 updated by: Anterogen Co., Ltd.
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.
Study Overview
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 110-744
- Seoul National University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: ANT-SM
autologous adipose-derived stem cell
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autologous adipose-derived stem cell
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Efficacy: Wexner's score evaluation
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Safety: Clinically measured abnormality of laboratory tests and adverse events
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Secondary Outcome Measures
Outcome Measure |
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Anorectal manometry and endorectal ultrasound at week 4
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 10, 2009
First Submitted That Met QC Criteria
November 10, 2009
First Posted (ESTIMATE)
November 11, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
March 10, 2011
Last Update Submitted That Met QC Criteria
March 8, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANT-SM-101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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