- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04612465
Clinical Study to Evaluate Efficacy and Safety of ASC and Fibringlue or Fibringlue in Patients With Crohn's Fistula
August 23, 2023 updated by: Anterogen Co., Ltd.
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Experimental: ASC(Autologous Adipose-derived Stem Cells) and Fibringlue, Comparator: Fibringlue, Study type: Interventional, Study design: Randomized
Study Type
Interventional
Enrollment (Estimated)
36
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: KyuJoo Park, MD. Ph D
- Phone Number: +82-02-2072-2901
- Email: kjparkmd@plaza.snu.ac.kr
Study Locations
-
-
-
Seoul, Korea, Republic of, 05505
- Recruiting
- Asan Medical Center
-
Contact:
- ChangSik Yu, MD. Ph D
- Phone Number: +82-02-3010-3494
- Email: csyu@amc.seoul.kr
-
Seoul, Korea, Republic of, 06351
- Recruiting
- Samsung Medical Center
-
Contact:
- YongBeom Cho, MD. Ph D
- Email: yongbeom.cho@samsung.com
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Seoul, Korea, Republic of, 03080
- Recruiting
- Seoul Natinoal Univetsity Hospital
-
Contact:
- KyuJoo Park, MD. Ph D
- Phone Number: +82-02-2072-2901
- Email: kjparkmd@plaza.snu.ac.kr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ASC (test arm)
(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.
Other Names:
|
Placebo Comparator: Fibringlue
Standard comparator
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of subjects who are completely blocked fistula
Time Frame: In the 8th week after 1st injection
|
complete blockage
|
In the 8th week after 1st injection
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of subjects who are completely blocked fistula
Time Frame: During 12 months after injection
|
complete blockage
|
During 12 months after injection
|
Proportion of subjects who are more than 50% blocked fistula
Time Frame: During 12 months after injection
|
50% blockage
|
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
|
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.
|
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
|
Radiology test is performed to subjects who are completely blocked fistula.
|
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)
|
Visual improvement effect of perianal fistula wound is evaluated by photograph of perianal fistula wound before and after the injection(intervention).
|
Immediately before and after the injection(intervention) and during 12 months after injection(intervention)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: KyuJoo Park, MD. Ph D, Seoul National University Hospital
- Principal Investigator: ChangSik Yu, MD. Ph D, Asan Medical Center
- Principal Investigator: YongBeom Cho, MD. Ph D, Samsung Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 9, 2020
Primary Completion (Estimated)
June 30, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
October 6, 2020
First Submitted That Met QC Criteria
October 27, 2020
First Posted (Actual)
November 3, 2020
Study Record Updates
Last Update Posted (Actual)
August 25, 2023
Last Update Submitted That Met QC Criteria
August 23, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANTG-ASC-301
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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