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

Fecal Incontinence Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01011686
• Other study ID #: ANT-SM-101
• Status: Terminated
• Phase: Phase 1
• First received: November 10, 2009
• Last updated: March 8, 2011

Study information

• Verified date: March 2011
• Source: Anterogen Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

N/A

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Biological:
• ANT-SM
autologous adipose-derived stem cell

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Anterogen Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Wexner's score evaluation			Yes
Primary	Safety: Clinically measured abnormality of laboratory tests and adverse events			Yes
Secondary	Anorectal manometry and endorectal ultrasound at week 4