Crohn's DiseaseANTG-ASC-203NCT01314079
Follow-up Study of Autologous Cultured Adipose-derived Stem Cells for the Crohn's Fistula
An observational study of Crohn's Disease and Fistula, run by Anterogen Co., Ltd. at 3 sites in South Korea.
Trial summary
This is an open follow-up clinical trials to evaluate a sustained efficacy and safety of Adipoplus inj. for 10 months (12 months after final dose injection)after Phase II clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease, Fistula
- How many people
- 37 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Apr 2010to Aug 2012
- Phase
- Observational
- 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
Study population: The patients who have participated in phase II clinical trial (ANTG-ASC-202) and injected with Adipoplus at least once.
Who may be able to join
- the patients who have participated in ANTG-ASC-202 clinical trial
- the patients who have experienced with Adipoplus in ANTG-ASC-202 trials
- the patients who submit written consents and is able to obey requirements of trials
Who cannot join
- pregnant or breast feeding
- autoimmune disease other than Crohn's disease
- infectious diseases including HBV, HCV or HIV
- who is not willing to use effective contraceptive methods during the study.
- active tuberculosis
- moderate to severe active or worsened Crohn's disease
- who have received Infliximab during or after ANTG-ASC-202 trial
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
DaeHang Hospital
Seoul
Samsung Medical Center
Seoul
Seoul Asan Hospital
Seoul
About this study
Official title: Follow-up Study to Evaluate the Sustained Efficacy and Safety for the Patients With Adipoplus Injected in Phase II Clinical Trials(ANTG-ASC-202)
This is an open follow-up clinical trials to evaluate a sustained efficacy and safety of Adipoplus inj. for 10 months (12 months after final dose injection)after Phase II clinical trial.
- Conditions
- Crohn's Disease, Fistula
- Keywords
- Crohn's fistula, Autologous adipose derived stem cell
- Medical subject headings
- Crohn Disease, Fistula
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Sustained efficacy of complete closure of fistula
Proportion of patients whose fistula has been completely closed.
Measured: Month 4, 10
Secondary outcomes (3)
Number of patients with sustained efficacy of closure of fistula
Proportion of patients with more than 50% closed of fistula (Month 2, 4, 10)
Measured: Month 2, 4, 10
Number of patients with any adverse event
number of patients with any adverse event (Month 2, 4, 10)
Measured: Month 2, 4, 10
Grade of Investigator's satisfaction
Grade of Investigator's satisfaction (Month 2, 4, 10)
- very satisfaction
- satisfacttion
- somewhat satisfaction
- unsatisfaction
- very unsatisfaction
Measured: Month 2, 4, 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study startApr 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anterogen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- CS You, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314079
- Sponsor's protocol ID
- ANTG-ASC-203
- Acronym
- ANTG-ASC-203
- Status last verified
- Mar 2012
- First submitted
- 8 Mar 2011
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Study to Evaluate the Sustained Efficacy and Safety for the Patients With Adipoplus Injected in Phase II Clinical Trials(ANTG-ASC-202)
- ClinicalTrials.gov ID
- NCT01314079
- Acronym / sponsor ID
- ANTG-ASC-203 / ANTG-ASC-203
- Conditions
- Crohn's Disease, Fistula
- Keywords
- Crohn's fistula, Autologous adipose derived stem cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Anterogen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 14 Mar 2011 (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.
This is an open follow-up clinical trials to evaluate a sustained efficacy and safety of Adipoplus inj. for 10 months (12 months after final dose injection)after Phase II clinical trial.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who have participated in phase II clinical trial (ANTG-ASC-202) and injected with Adipoplus at least once.
Key inclusion criteria (3 listed)
- the patients who have participated in ANTG-ASC-202 clinical trial
- the patients who have experienced with Adipoplus in ANTG-ASC-202 trials
- the patients who submit written consents and is able to obey requirements of trials
Key exclusion criteria (7 listed)
- pregnant or breast feeding
- autoimmune disease other than Crohn's disease
- infectious diseases including HBV, HCV or HIV
- who is not willing to use effective contraceptive methods during the study.
- 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.
Primary outcome
Number of patients with Sustained efficacy of complete closure of fistula
Time frame: Month 4, 10
Proportion of patients whose fistula has been completely closed.
3 secondary outcomes
Number of patients with sustained efficacy of closure of fistula
Time frame: Month 2, 4, 10
Number of patients with any adverse event
Time frame: Month 2, 4, 10
Grade of Investigator's satisfaction
Time frame: Month 2, 4, 10
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 23 Nov 2016.
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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 You, MD, PhD principal investigator
Asan Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease and Fistula, run by Anterogen Co., Ltd. at 3 sites 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 3 inclusion and 7 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 23 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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?
Number of patients with Sustained efficacy of complete closure of fistula (time frame: Month 4, 10). 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 23 Nov 2016.