Clinical trial NCT04612465: 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
Overall status: RECRUITING
Phase: PHASE3
Conditions: Crohn's Fistula
Lead sponsor: Anterogen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-11-03
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: Inclusion Criteria:

1. Patient who has obtained the consent of their legal representative if they are over 18 years of age and under 20 years of age.
2. Patient is diagnosed with Crohn's disease.
3. Patient who has one or more Crohn's fistulas .
4. In the case of women of childbearing potential, patient who is negative for beta-HCG pregnancy tests at the screening visit.
5. Patient is able to give written informed consent prior to study start and willing to comply with the study requirements.

Exclusion Criteria:

1. 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.
2. Patient with a medical history or family history of Variant Creutzfeld Jakob Disease or related to this disease.
3. Patient who is sensitive to anesthetic drugs or bovine-derived materials.
4. Patient with autoimmune disease except for Crohn's disease.
5. Patient with infectious diseases such as HBV, HCV and HIV.
6. Patient with signs of Septicemia.
7. Patient with Active Tuberculosis.(Including patient with Anal Tuberculosis)
8. Pregnant or breast-feeding.
9. . Is unwilling to use an acceptable method of birth control during the whole study.
10. Patient with Inflammatory Bowel disease except for Crohn's disease.
11. Patient who is sensitive to Fibringlue.
12. Patient with a clinically relevant history of alcohol or drugs abuse, habitual smoking.
13. Patient whose adipose tissue obtained by liposuction is insufficient to manufacture the Investigational product at the intended dose.
14. Patient who is not able to understand the objective of the study or to comply with the study requirements.
15. Patient who is considered by the investigator to have a significant disease which might impact the study.
16. Patient who is considered not suitable for the study by investigator.
17. Patient who is Active Crohn's disease with CDAI 450 or higher.
18. Patient with medical history of surgery for malignant cancer in the past 5 years.(Except for carcinoma in situ)
19. Patient who exceeds 2 cm in the longest diameter of fistula.
20. Patient who dosed anti-TNF formulations such as infliximab, adalimumab, certolizumab within 3 months prior to injection.

Primary outcomes:
measure: Proportion of subjects who are completely blocked fistula
timeFrame: In the 8th week after 1st injection
Secondary outcomes:
measure: Proportion of subjects who are completely blocked fistula
timeFrame: During 12 months after injection
measure: Proportion of subjects who are more than 50% blocked fistula
timeFrame: During 12 months after injection
measure: Score of evaluation about Investigator satisfaction using questionnaire
timeFrame: In the 8th week, 6th month and 12th month after final injection
measure: Proportion of subjects who are confirmed maintenance of fistula blockage by radiology test
timeFrame: Between 6th month and 12th month after final injection
measure: Visual improvement effect of perianal fistula wound through photography of it
timeFrame: Immediately before and after the injection(intervention) and during 12 months after injection(intervention)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Natinoal Univetsity Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Seoul National University Hospital
name: KyuJoo Park, MD. Ph D
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: ChangSik Yu, MD. Ph D
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: YongBeom Cho, MD. Ph D
role: PRINCIPAL_INVESTIGATOR
References: