Back to resultsClinical Study to Evaluate Efficacy and Safety of ASC and Fibringlue or Fibringlue in Patients With Crohn's Fistula
Primary Purpose
Crohn's Fistula
Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ASC
Fibringlue
Sponsored by
About this trial
This is an interventional prevention trial for Crohn's Fistula
Eligibility Criteria
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.
Sites / Locations
- Seoul Natinoal Univetsity HospitalRecruiting
- Asan Medical CenterRecruiting
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ASC (test arm)
Fibringlue
Arm Description
(Autologous Adipose-derived Mesenchymal Stem Cells)
Standard comparator
Outcomes
Primary Outcome Measures
Proportion of subjects who are completely blocked fistula
complete blockage
Secondary Outcome Measures
Proportion of subjects who are completely blocked fistula
complete blockage
Proportion of subjects who are more than 50% blocked fistula
50% blockage
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.
Proportion of subjects who are confirmed maintenance of fistula blockage by radiology test
Radiology test is performed to subjects who are completely blocked fistula.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04612465
Brief Title
Clinical Study to Evaluate Efficacy and Safety of ASC and Fibringlue or Fibringlue in Patients With Crohn's Fistula
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2020 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anterogen Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
Experimental: ASC(Autologous Adipose-derived Stem Cells) and Fibringlue, Comparator: Fibringlue, Study type: Interventional, Study design: Randomized
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Fistula
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ASC (test arm)
Arm Type
Experimental
Arm Description
(Autologous Adipose-derived Mesenchymal Stem Cells)
Arm Title
Fibringlue
Arm Type
Placebo Comparator
Arm Description
Standard comparator
Intervention Type
Biological
Intervention Name(s)
ASC
Other Intervention Name(s)
(Autologous Adipose-derived Mesenchymal Stem Cells)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Fibringlue
Other Intervention Name(s)
standard control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of subjects who are completely blocked fistula
Description
complete blockage
Time Frame
In the 8th week after 1st injection
Secondary Outcome Measure Information:
Title
Proportion of subjects who are completely blocked fistula
Description
complete blockage
Time Frame
During 12 months after injection
Title
Proportion of subjects who are more than 50% blocked fistula
Description
50% blockage
Time Frame
During 12 months after injection
Title
Score of evaluation about Investigator satisfaction using questionnaire
Description
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.
Time Frame
In the 8th week, 6th month and 12th month after final injection
Title
Proportion of subjects who are confirmed maintenance of fistula blockage by radiology test
Description
Radiology test is performed to subjects who are completely blocked fistula.
Time Frame
Between 6th month and 12th month after final injection
Title
Visual improvement effect of perianal fistula wound through photography of it
Description
Visual improvement effect of perianal fistula wound is evaluated by photograph of perianal fistula wound before and after the injection(intervention).
Time Frame
Immediately before and after the injection(intervention) and during 12 months after injection(intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
KyuJoo Park, MD. Ph D
Phone
+82-02-2072-2901
Email
kjparkmd@plaza.snu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KyuJoo Park, MD. Ph D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ChangSik Yu, MD. Ph D
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
YongBeom Cho, MD. Ph D
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul Natinoal Univetsity Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KyuJoo Park, MD. Ph D
Phone
+82-02-2072-2901
Email
kjparkmd@plaza.snu.ac.kr
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ChangSik Yu, MD. Ph D
Phone
+82-02-3010-3494
Email
csyu@amc.seoul.kr
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YongBeom Cho, MD. Ph D
Email
yongbeom.cho@samsung.com
12. IPD Sharing Statement
Learn more about this trial
Clinical Study to Evaluate Efficacy and Safety of ASC and Fibringlue or Fibringlue in Patients With Crohn's Fistula
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