Safety Study of Autologous Cultured Adipose -Derived Stem Cells for the Fecal Incontinence
Phase 1
Terminated
- Conditions
- Fecal Incontinence
- Interventions
- Biological: ANT-SM
- Registration Number
- NCT01011686
- Lead Sponsor
- Anterogen Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- Not specified
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ANT-SM ANT-SM autologous adipose-derived stem cell
- Primary Outcome Measures
Name Time Method Efficacy: Wexner's score evaluation Safety: Clinically measured abnormality of laboratory tests and adverse events
- Secondary Outcome Measures
Name Time Method Anorectal manometry and endorectal ultrasound at week 4
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of