Fecal Incontinence
Conditions
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.
Interventions
BIOLOGICALANT-SM
autologous adipose-derived stem cell
Sponsors
Anterogen Co., Ltd.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Wexner's score evaluation | — |
| Safety: Clinically measured abnormality of laboratory tests and adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Anorectal manometry and endorectal ultrasound at week 4 | — |
Countries
South Korea
Outcome results
None listed