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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I Clinical Study of ANT-SM (Autologous Cultured Adipose-derived Stem Cell) for the Treatment of Fecal Incontinence to Evaluate Safety

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Biological: ANT-SM


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ANT-SM<br>autologous adipose-derived stem cell | Biological: ANT-SM<br>* autologous adipose-derived stem cell<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Wexner's score evaluation |  |  | 
| Safety: Clinically measured abnormality of laboratory tests and adverse events |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anorectal manometry and endorectal ultrasound at week 4 |  |  |