Crohn's FistulaPhase 2NCT01011244
Safety and Efficacy Study of Autologous Cultured Adipose -Derived Stem Cells for the Crohn's Fistula
A Phase 2 study testing ADIPOPLUS in people with Crohn's Fistula, run by Anterogen Co., Ltd. at 1 site in South Korea.
Trial summary
Up to date, a sure cure for Crohn's fistula does not known and the fistula recurrence rate is high. On 15 October 2008, orphan designation was granted by Korea FDA for human adipose-derived stem cell (ADIPOPLUS) for the treatment of Crohn's fistula. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Fistula
- What is being tested?
- ADIPOPLUS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2010to Sep 2011
- Phase
- Phase 2
- 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
- Prior diagnosis of Crohn's disease
- patients who have Crohn's fistula
- negative for serum beta-HCG for woman of childbearing age
- agreement to participate, with signed informed-consent
Who cannot join
- patients who have allergy to bovine-derived materials or an anesthetic
- patients with a diagnosis of auto immune disease except for Crohn's disease
- Diagnosis of HBV, HCV, HIV and other infectious disease
- Patients who have a symptom of septicemia
- Patients with a diagnosis of active Tuberculosis
- Patient who are pregnant or breast-feeding
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- Patients who are unwilling to use an "effective" method of contraception during the study
- Patients with a diagnosis of Inflammatory Bowel Disease except for Crohn's disease
- Patients who are sensitive to Fibrin glue
- Patients who have a clinically relevant history of abuse of alcohol or drugs, habitual smoker
- Insufficient adipose tissue for manufacturing of ADIPOPLUS
- Patients who are considered not suitable for the study by investigator
- Patients with a diagnosis of active refractory Crohn's disease
- Patients who have history of surgery for malignant cancer in the past 5 years
- Patients who have > 2 cm diameter of fistula
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Clinical Study of ADIPOPLUS (Autologous Cultured Adipose-derived Stem Cell) for the Treatment of Crohn's Fistula to Evaluate Safety and Efficacy
Up to date, a sure cure for Crohn's fistula does not known and the fistula recurrence rate is high. On 15 October 2008, orphan designation was granted by Korea FDA for human adipose-derived stem cell (ADIPOPLUS) for the treatment of Crohn's fistula. In this study, patients are given injection of ADIPOPLUS in fistula site and followed for 8 weeks to evaluate the safety and efficacy.
- Conditions
- Crohn's Fistula
- Being tested
- ADIPOPLUS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADIPOPLUSBiological
Also called ANTG-ASC
autologous cultured adipose-derived stem cells
1x10e7 cells/1cm2 depending on surface area of fistula
| Study group | Role | What they receive |
|---|---|---|
| ADIPOPLUS | Experimental | patients with a fistula in Crohn's disease Receives: Biological: ADIPOPLUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: complete closure of fistula at week 8
Measured: 8 weeks
number of patients with any adverse event
Measured: Day 0, Week 8
Secondary outcomes (4)
Photo of target fistula
taking Photo of target fistula : Day 0, week 4, 6, 8
Measured: 8 weeks
number of patients with any adverse events
Adverse reaction : day 0, Week 4, 6, 8
Measured: 8 weeks
number of patients with complete closure of fistula
complete closure : every visits more than 50% closure of fistula : every visits
Measured: 8 weeks
Investigator's satisfaction
Investigator's satisfaction : week 8
Measured: 8 weeks
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)
- Study startFeb 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's FistulaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anterogen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- CS Yu, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011244
- Sponsor's protocol ID
- ANTG-ASC-202
- Status last verified
- Mar 2012
- First submitted
- 10 Nov 2009
- Last updated
- 15 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study of ADIPOPLUS (Autologous Cultured Adipose-derived Stem Cell) for the Treatment of Crohn's Fistula to Evaluate Safety and Efficacy
- ClinicalTrials.gov ID
- NCT01011244
- Acronym / sponsor ID
- ANTG-ASC-202
- Conditions
- Crohn's Fistula
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Anterogen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- 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.
Up to date, a sure cure for Crohn's fistula does not known and the fistula recurrence rate is high. On 15 October 2008, orphan designation was granted by Korea FDA for human adipose-derived stem cell (ADIPOPLUS) for the treatment of Crohn's fistula. In this study, patients are given injection of ADIPOPLUS in fistula site and followed for 8 weeks to evaluate the safety and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADIPOPLUS | Experimental | Biological: ADIPOPLUSpatients with a fistula in Crohn's disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Older than 18 years
- Prior diagnosis of Crohn's disease
- patients who have Crohn's fistula
- negative for serum beta-HCG for woman of childbearing age
- agreement to participate, with signed informed-consent
Key exclusion criteria (15 listed)
- patients who have allergy to bovine-derived materials or an anesthetic
- patients with a diagnosis of auto immune disease except for Crohn's disease
- Diagnosis of HBV, HCV, HIV and other infectious disease
- Patients who have a symptom of septicemia
- 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 |
|---|---|---|
| ADIPOPLUSAlso: ANTG-ASCautologous cultured adipose-derived stem cells 1x10e7 cells/1cm2 depending on surface area of fistula | Biological | ADIPOPLUS |
Primary outcome
Efficacy: complete closure of fistula at week 8
Time frame: 8 weeks
number of patients with any adverse event
Time frame: Day 0, Week 8
4 secondary outcomes
Photo of target fistula
Time frame: 8 weeks
number of patients with any adverse events
Time frame: 8 weeks
number of patients with complete closure of fistula
Time frame: 8 weeks
Investigator's satisfaction
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2012.
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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.
CS Yu, MD, PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ADIPOPLUS in people with Crohn's Fistula, 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 5 inclusion and 15 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: finished, as of the sponsor's last update on 15 Mar 2012. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: complete closure of fistula at week 8 (time frame: 8 weeks). 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 15 Mar 2012.