Crohn's FistulaPhase 3NCT04612465
Clinical Study to Evaluate Efficacy and Safety of ASC and Fibringlue or Fibringlue in Patients With Crohn's Fistula
A Phase 3 study testing ASC and Fibringlue in people with Crohn's Fistula, run by Anterogen Co., Ltd. at 4 sites in South Korea.
Trial summary
This is a phase III study to evaluate the efficacy and safety of ASC(Autologous Adipose-derived Stem Cells) and Fibringlue or Fibringlue in Patients With 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?
- ASC and Fibringlue
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 9 Jan 2020to 23 Sep 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Patient who has obtained the consent of their legal representative if they are over 18 years of age and under 20 years of age.
- Patient is diagnosed with Crohn's disease.
- Patient who has one or more Crohn's fistulas .
- In the case of women of childbearing potential, patient who is negative for beta-HCG pregnancy tests at the screening visit.
- Patient is able to give written informed consent prior to study start and willing to comply with the study requirements.
Who cannot join
- Patient who participated in other clinical trials within 30 days prior to the start of this clinical trial, or who has not passed a period equal to five times of the half-life of the drug dosed in other clinical trials.
- Patient with a medical history or family history of Variant Creutzfeld Jakob Disease or related to this disease.
- Patient who is sensitive to anesthetic drugs or bovine-derived materials.
- Patient with autoimmune disease except for Crohn's disease.
- Patient with infectious diseases such as HBV, HCV and HIV.
- Patient with signs of Septicemia.
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- Patient with Active Tuberculosis.(Including patient with Anal Tuberculosis)
- Pregnant or breast-feeding.
- . Is unwilling to use an acceptable method of birth control during the whole study.
- Patient with Inflammatory Bowel disease except for Crohn's disease.
- Patient who is sensitive to Fibringlue.
- Patient with a clinically relevant history of alcohol or drugs abuse, habitual smoking.
- Patient whose adipose tissue obtained by liposuction is insufficient to manufacture the Investigational product at the intended dose.
- Patient who is not able to understand the objective of the study or to comply with the study requirements.
- Patient who is considered by the investigator to have a significant disease which might impact the study.
- Patient who is considered not suitable for the study by investigator.
- Patient who is Active Crohn's disease with CDAI 450 or higher.
- Patient with medical history of surgery for malignant cancer in the past 5 years.(Except for carcinoma in situ)
- Patient who exceeds 2 cm in the longest diameter of fistula.
- Patient who dosed anti-TNF formulations such as infliximab, adalimumab, certolizumab within 3 months prior to injection.
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Severance
Seoul, Seodaemun-gu, 03722
Seoul Natinoal Univetsity Hospital
Seoul, Seoul, 03080
Asan Medical Center
Seoul, Seoul, 05505
Samsung Medical Center
Seoul, Seoul, 06351
About this study
Official title: Phase 3 Clinical Study to Evaluate Efficacy and Safety of ASC(Autologous Adipose-derived Stem Cells) and Fibringlue or Fibringlue in Patients With Crohn's Fistula.: A Randomized Study
This is a phase III study to evaluate the efficacy and safety of ASC(Autologous Adipose-derived Stem Cells) and Fibringlue or Fibringlue in Patients With Crohn's Fistula.
Read the detailed description
Experimental: ASC(Autologous Adipose-derived Stem Cells) and Fibringlue, Comparator: Fibringlue, Study type: Interventional, Study design: Randomized
- Conditions
- Crohn's Fistula
- Being tested
- ASC, Fibringlue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASCBiological
Also called (Autologous Adipose-derived Mesenchymal Stem Cells)
Injection of ASC(Autologous Adipose-derived Mesenchymal Stem Cells) to Crohn's Fistula.
The ASC injection dose is about 1x10^7 cells of ASC per 1cm^2 of the surface area of the fistula, and the additional injection dose is 1.5 times the initial injection dose. and up to 30% of the ASC injection dose is administered in combination with Fibringlu.
FibringlueDrug
Also called standard control
Injection of Fibringlue to Crohn's Fistula. The Fibringlu injection dose is given the size of the fistula that is fill the entire fistula, and the additional injection dose is the same.
| Study group | Role | What they receive |
|---|---|---|
| ASC (test arm) | Experimental | (Autologous Adipose-derived Mesenchymal Stem Cells) Receives: Biological: ASC |
| Fibringlue | Placebo comparator | Standard comparator Receives: Drug: Fibringlue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who are completely blocked fistula
complete blockage
Measured: In the 8th week after 1st injection
Secondary outcomes (5)
Proportion of subjects who are completely blocked fistula
complete blockage
Measured: During 12 months after injection
Proportion of subjects who are more than 50% blocked fistula
50% blockage
Measured: During 12 months after injection
Score of evaluation about Investigator satisfaction using questionnaire
Score of evaluation about Investigator satisfaction range from 1 to 5. The lower this score, it means that the higher investigator's satisfaction with treatment effect of investigational product.
Measured: In the 8th week, 6th month and 12th month after final injection
Proportion of subjects who are confirmed maintenance of fistula blockage by radiology test
Radiology test is performed to subjects who are completely blocked fistula.
Measured: Between 6th month and 12th month after final injection
Visual improvement effect of perianal fistula wound through photography of it
Visual improvement effect of perianal fistula wound is evaluated by photograph of perianal fistula wound before and after the injection(intervention).
Measured: Immediately before and after the injection(intervention) and during 12 months after injection(intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start9 Jan 2020
- Primary completion8 Apr 2025
- Study completion23 Sep 2025 (estimated)
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anterogen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- KyuJoo Park, MD. Ph D, Principal investigator, Seoul National University HospitalChangSik Yu, MD. Ph D, Principal investigator, Asan Medical CenterYongBeom Cho, MD. Ph D, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612465
- Sponsor's protocol ID
- ANTG-ASC-301
- Status last verified
- Sep 2025
- First submitted
- 6 Oct 2020
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Clinical Study to Evaluate Efficacy and Safety of ASC(Autologous Adipose-derived Stem Cells) and Fibringlue or Fibringlue in Patients With Crohn's Fistula.: A Randomized Study
- ClinicalTrials.gov ID
- NCT04612465
- Acronym / sponsor ID
- ANTG-ASC-301
- Conditions
- Crohn's Fistula
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Anterogen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 8 Apr 2025 (actual)
- Study completion
- 23 Sep 2025 (estimated)
- First posted
- 3 Nov 2020 (actual)
- 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 a phase III study to evaluate the efficacy and safety of ASC(Autologous Adipose-derived Stem Cells) and Fibringlue or Fibringlue in Patients With Crohn's Fistula.
Detailed description
Experimental: ASC(Autologous Adipose-derived Stem Cells) and Fibringlue, Comparator: Fibringlue, Study type: Interventional, Study design: Randomized
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASC (test arm) | Experimental | Biological: ASC(Autologous Adipose-derived Mesenchymal Stem Cells) |
| Fibringlue | Placebo comparator | Drug: FibringlueStandard comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient who has obtained the consent of their legal representative if they are over 18 years of age and under 20 years of age.
- Patient is diagnosed with Crohn's disease.
- Patient who has one or more Crohn's fistulas .
- In the case of women of childbearing potential, patient who is negative for beta-HCG pregnancy tests at the screening visit.
- Patient is able to give written informed consent prior to study start and willing to comply with the study requirements.
Key exclusion criteria (20 listed)
- Patient who participated in other clinical trials within 30 days prior to the start of this clinical trial, or who has not passed a period equal to five times of the half-life of the drug dosed in other clinical trials.
- Patient with a medical history or family history of Variant Creutzfeld Jakob Disease or related to this disease.
- Patient who is sensitive to anesthetic drugs or bovine-derived materials.
- Patient with autoimmune disease except for Crohn's disease.
- Patient with infectious diseases such as HBV, HCV and 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 |
|---|---|---|
| ASCAlso: (Autologous Adipose-derived Mesenchymal Stem Cells)Injection of ASC(Autologous Adipose-derived Mesenchymal Stem Cells) to Crohn's Fistula. The ASC injection dose is about 1x10^7 cells of ASC per 1cm^2 of the surface area of the fistula, and the additional injection dose is 1.5 times the initial injection dose. and up to 30% of the ASC injection dose is administered in combination with Fibringlu. | Biological | ASC (test arm) |
| FibringlueAlso: standard controlInjection of Fibringlue to Crohn's Fistula. The Fibringlu injection dose is given the size of the fistula that is fill the entire fistula, and the additional injection dose is the same. | Drug | Fibringlue |
Primary outcome
Proportion of subjects who are completely blocked fistula
Time frame: In the 8th week after 1st injection
complete blockage
5 secondary outcomes
Proportion of subjects who are completely blocked fistula
Time frame: During 12 months after injection
Proportion of subjects who are more than 50% blocked fistula
Time frame: During 12 months after injection
Score of evaluation about Investigator satisfaction using questionnaire
Time frame: In the 8th week, 6th month and 12th month after final injection
Proportion of subjects who are confirmed maintenance of fistula blockage by radiology test
Time frame: Between 6th month and 12th month after final injection
Visual improvement effect of perianal fistula wound through photography of it
Time frame: Immediately before and after the injection(intervention) and during 12 months after injection(intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
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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.
KyuJoo Park, MD. Ph D principal investigator
Seoul National University Hospital
ChangSik Yu, MD. Ph D principal investigator
Asan Medical Center
YongBeom Cho, MD. Ph D principal investigator
Samsung Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ASC and Fibringlue in people with Crohn's Fistula, run by Anterogen Co., Ltd. at 4 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 5 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of subjects who are completely blocked fistula (time frame: In the 8th week after 1st injection). 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 29 Sep 2025.