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.

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)