Safety Study of Autologous Cultured Adipose -Derived Stem... | NCT01011686

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

NCT01011686

Sponsor

Anterogen Co., Ltd.

Status

Terminated

Last Update Posted

Mar 10, 2011Estimated

Enrollment

Not provided

Phase

Phase 1

Conditions

Fecal Incontinence

Interventions

ANT-SM

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Few subject enrolled

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 10, 2009

First Submission Date that Met QC Criteria

Nov 10, 2009

First Posted Date

Nov 11, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2011

Last Update Posted Date

Mar 10, 2011Estimated

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Label	Type	Description	Intervention Names
ANT-SM	Experimental	autologous adipose-derived stem cell	Biological: ANT-SM

Name	Type	Description	Arm Group Labels	Other Names
ANT-SM	Biological	autologous adipose-derived stem cell	ANT-SM

Measure	Description	Time Frame
Anorectal manometry and endorectal ultrasound at week 4

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D012002	Rectal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Measure	Description	Time Frame
Efficacy: Wexner's score evaluation
Safety: Clinically measured abnormality of laboratory tests and adverse events