Fecal IncontinencePhase 1NCT01011686
Safety Study of Autologous Cultured Adipose -Derived Stem Cells for the Fecal Incontinence
A Phase 1 study testing ANT-SM in people with Fecal Incontinence, run by Anterogen Co., Ltd. at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- ANT-SM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteSouth Korea
- Study dates
- Start not givento not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Fecal Incontinence
- Being tested
- ANT-SM
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANT-SMBiological
autologous adipose-derived stem cell
| Study group | Role | What they receive |
|---|---|---|
| ANT-SM | Experimental | autologous adipose-derived stem cell Receives: Biological: ANT-SM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Wexner's score evaluation
Safety: Clinically measured abnormality of laboratory tests and adverse events
Secondary outcomes (1)
Anorectal manometry and endorectal ultrasound at week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
Why it stopped: Few subject enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
Sponsor and investigators
- Lead sponsor
- Anterogen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011686
- Sponsor's protocol ID
- ANT-SM-101
- Status last verified
- Mar 2011
- First submitted
- 10 Nov 2009
- Last updated
- 10 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01011686
- Acronym / sponsor ID
- ANT-SM-101
- Conditions
- Fecal Incontinence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Few subject enrolled
- Lead sponsor
- Anterogen Co., Ltd.Industry (pharma, biotech, devices)
- First posted
- 11 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ANT-SM | Experimental | Biological: ANT-SMautologous adipose-derived stem cell |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANT-SMautologous adipose-derived stem cell | Biological | ANT-SM |
Primary outcome
Efficacy: Wexner's score evaluation
Safety: Clinically measured abnormality of laboratory tests and adverse events
1 secondary outcome
Anorectal manometry and endorectal ultrasound at week 4
Results and safety
The study was stopped early (reason given: Few subject enrolled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ANT-SM in people with Fecal Incontinence, run by Anterogen Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Few subject enrolled). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: Wexner's score evaluation. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2011.