Safety Study of Autologous Cultured Adipose -Derived Stem Cells for the Fecal Incontinence
This study has been terminated.
(Few subject enrolled)
Sponsor:
Anterogen Co., Ltd.
Information provided by:
Anterogen Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01011686
First received: November 10, 2009
Last updated: March 8, 2011
Last verified: March 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fecal Incontinence |
Biological: ANT-SM |
Phase 1 |
| Study Type: | Interventional |
| Official Title: | A Phase I Clinical Study of ANT-SM (Autologous Cultured Adipose-derived Stem Cell) for the Treatment of Fecal Incontinence to Evaluate Safety |
Resource links provided by NLM:
Further study details as provided by Anterogen Co., Ltd.:
Primary Outcome Measures:
- Efficacy: Wexner's score evaluation [ Designated as safety issue: Yes ]
- Safety: Clinically measured abnormality of laboratory tests and adverse events [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Anorectal manometry and endorectal ultrasound at week 4
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ANT-SM
autologous adipose-derived stem cell
|
Biological: ANT-SM
autologous adipose-derived stem cell
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT01011686 History of Changes |
| Other Study ID Numbers: | ANT-SM-101 |
| Study First Received: | November 10, 2009 |
| Last Updated: | March 8, 2011 |
| Health Authority: | Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
Fecal Incontinence Rectal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013