Complex Perianal FistulaPhase 2ANTG-ASC-210NCT01314092
Clinical Trials of Autologous Cultured Adipose-derived Stem Cells (ANTG-ASC) on Complex Fistula
A Phase 2 study testing Autologous cultured adipose derived stem cells(low dose group) and Autologous cultured adipose derived stem cells(high dose group) in people with Complex Perianal Fistula, run by Anterogen Co., Ltd. at 6 sites in South Korea.
Trial summary
Mesenchymal stem cells derived from adipose tissue are pluripotent to differentiate into myocytes, adipocytes or others. They have an immunosuppressive activity. Complex perianal fistula is difficult to cure and easy to relapse. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Perianal Fistula
- What is being tested?
- Autologous cultured adipose derived stem cells(low dose group) and Autologous cultured adipose derived stem cells(high dose group)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 6 sitesSouth Korea
- Study dates
- Jan 2011to Sep 2014
- 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
- a patient who has complex perianal fistula
- a patient who is negative in pregnancy test
- a patient who has submitted a written consent
Who cannot join
- a patient who has participated in other clinical studies within 30 days before this clinical trial or has not passed 5 fold period of a half-life of other investigational drugs.
- a patient who has a history of variant Creutzfeldt Jacobs disease or related diseases
- a patient who is allergic to anesthetics, bovine derived proteins or a fibrin glue
- a patient who has an autoimmune disease
- a patient who has infectious diseases such as hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
- a patient who has sepsis or active tuberculosis
Show all 9Show fewer
- a patient who is pregnant or breast feeding
- a patient who has inflammatory Bowel disease
- over 2cm in diameter of fistula
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Soon cheun Hyang university bucheon hospital
Bucheon-si, 420-767
Ewha womwn university mokdong hospital
Seoul, 158-710
DaeHang Hospital
Seoul
Samsung seoul Hospital
Seoul
Seoul National University Hospital
Seoul
Seoul Saint Mary's Hospital
Seoul
About this study
Official title: Phase II Study to Evaluate Efficacy and Safety of ANTG-ASC (Autologous Cultured Adipose-derived Stem Cells) on the Complex Fistula Patients
Mesenchymal stem cells derived from adipose tissue are pluripotent to differentiate into myocytes, adipocytes or others. They have an immunosuppressive activity. Complex perianal fistula is difficult to cure and easy to relapse. Autologous adipose stem cells have shown efficacy and safety on Crohn's fistula in phase 1 study. Based on these results, the investigators would apply autologous adipose stem cells on complex perianal fistula to evaluate their efficacy and safety.
- Conditions
- Complex Perianal Fistula
- Being tested
- Autologous cultured adipose derived stem cells(low dose group), Autologous cultured adipose derived stem cells(high dose group)
- Keywords
- crohn's disease, fistula, complex
- Medical subject headings
- Crohn Disease, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous cultured adipose derived stem cells(low dose group)Biological
Also called mesenchymal stem cell, ANTG-ASC, adipose derived stem cell, Group1: low dose group
low dose group: 1x10e7 cells/mL At 6 weeks after first stem cell injection, fistula closing was assessed. If it is not completely closed, second injection would be applied in 2 weeks. Additional dosage would be doubled to first dosage.
Autologous cultured adipose derived stem cells(high dose group)Biological
Also called mesenchymal stem cell, ANTG-ASC, adipose derived stem cell, Group2: high dose group
high dose group: 2x10e7 cells/mL At 6 weeks after first stem cell injection, fistula closing was assessed. If it is not completely closed, second injection would be applied in 2 weeks. Additional dosage would be doubled to first dosage.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Low dose group Receives: Biological: Autologous cultured adipose derived stem cells(low dose group) |
| Group 2 | Experimental | high dose group Receives: Biological: Autologous cultured adipose derived stem cells(high dose group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with complete closure of fistula (week 8)
Proportion of patients with completely closed fistula (week 8)
Measured: 8 weeks
Secondary outcomes (4)
Grade of investigator's satisfaction
Grade of investigator's satisfaction (8 weeks after final dose)
- very satisfaction
- satisfaction
- somewhat satisfaction
- unsatisfaction
- very unsatisfaction
Measured: 8 weeks
Number of patients with closed fistula
- proportion of patients with completely closed fistula (every visits)
- proportion of patients with more than 50 % closed fistula (every visits)
Measured: 8 weeks
Photo of target fistula
Taking picture of target fistula at Day 0 and Week 4, 6, 8
Measured: 8 weeks
Number of patients with adverse events
Number of patients with any kinds of adverse events (Day 0, every visits)
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 posted14 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionSep 2014
- Study completionSep 2014
Why it stopped: Difficulty recruiting subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Perianal 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anterogen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- KJ Park, MD, PhD, Principal investigator, Seoul National University HospitalDS Kim, Principal investigator, Daehang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314092
- Sponsor's protocol ID
- ANTG-ASC-210
- Acronym
- ANTG-ASC-210
- Status last verified
- Mar 2011
- First submitted
- 8 Mar 2011
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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
- Phase II Study to Evaluate Efficacy and Safety of ANTG-ASC (Autologous Cultured Adipose-derived Stem Cells) on the Complex Fistula Patients
- ClinicalTrials.gov ID
- NCT01314092
- Acronym / sponsor ID
- ANTG-ASC-210 / ANTG-ASC-210
- Conditions
- Complex Perianal Fistula
- Keywords
- crohn's disease, fistula, complex
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting subjects.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Anterogen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (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.
Mesenchymal stem cells derived from adipose tissue are pluripotent to differentiate into myocytes, adipocytes or others. They have an immunosuppressive activity. Complex perianal fistula is difficult to cure and easy to relapse. Autologous adipose stem cells have shown efficacy and safety on Crohn's fistula in phase 1 study. Based on these results, the investigators would apply autologous adipose stem cells on complex perianal fistula to evaluate their efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Autologous cultured adipose derived stem cells(low dose group)Low dose group |
| Group 2 | Experimental | Biological: Autologous cultured adipose derived stem cells(high dose group)high dose group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- a patient who has complex perianal fistula
- a patient who is negative in pregnancy test
- a patient who has submitted a written consent
Key exclusion criteria (9 listed)
- a patient who has participated in other clinical studies within 30 days before this clinical trial or has not passed 5 fold period of a half-life of other investigational drugs.
- a patient who has a history of variant Creutzfeldt Jacobs disease or related diseases
- a patient who is allergic to anesthetics, bovine derived proteins or a fibrin glue
- a patient who has an autoimmune disease
- a patient who has infectious diseases such as hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
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 |
|---|---|---|
| Autologous cultured adipose derived stem cells(low dose group)Also: mesenchymal stem cell, ANTG-ASC, adipose derived stem cell, Group1: low dose grouplow dose group: 1x10e7 cells/mL At 6 weeks after first stem cell injection, fistula closing was assessed. If it is not completely closed, second injection would be applied in 2 weeks. Additional dosage would be doubled to first dosage. | Biological | Group 1 |
| Autologous cultured adipose derived stem cells(high dose group)Also: mesenchymal stem cell, ANTG-ASC, adipose derived stem cell, Group2: high dose grouphigh dose group: 2x10e7 cells/mL At 6 weeks after first stem cell injection, fistula closing was assessed. If it is not completely closed, second injection would be applied in 2 weeks. Additional dosage would be doubled to first dosage. | Biological | Group 2 |
Primary outcome
Number of patients with complete closure of fistula (week 8)
Time frame: 8 weeks
Proportion of patients with completely closed fistula (week 8)
4 secondary outcomes
Grade of investigator's satisfaction
Time frame: 8 weeks
Number of patients with closed fistula
Time frame: 8 weeks
Photo of target fistula
Time frame: 8 weeks
Number of patients with adverse events
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Difficulty recruiting subjects.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Complex Perianal Fistula
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Crohn Disease
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A Survey of Darvadstrocel in People With Crohn's Disease
Crohn's Disease
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.
KJ Park, MD, PhD principal investigator
Seoul National University Hospital
DS Kim principal investigator
Daehang Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous cultured adipose derived stem cells(low dose group) and Autologous cultured adipose derived stem cells(high dose group) in people with Complex Perianal Fistula, run by Anterogen Co., Ltd. at 6 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 9 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 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 6 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.
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 was stopped early (reason given: Difficulty recruiting subjects.). 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?
Number of patients with complete closure of fistula (week 8) (time frame: 8 weeks). 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.