Clinical Study to Evaluate Efficacy and Safety of ASC and Fibringlue or Fibringlue in Patients With Crohn's Fistula

NCT ID: NCT04612465

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-09
• Study Completion Date: 2025-09-23

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

Conditions

Crohn's Fistula

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

ASC (test arm)

(Autologous Adipose-derived Mesenchymal Stem Cells)

Group Type: EXPERIMENTAL

ASC

Intervention Type: BIOLOGICAL

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.

Fibringlue

Standard comparator

Group Type: PLACEBO_COMPARATOR

Fibringlue

Intervention Type: DRUG

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.

Interventions

ASC

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: BIOLOGICAL

Fibringlue

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.

Intervention Type: DRUG

Other Intervention Names

(Autologous Adipose-derived Mesenchymal Stem Cells); standard control

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anterogen Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

KyuJoo Park, MD. Ph D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

ChangSik Yu, MD. Ph D

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

YongBeom Cho, MD. Ph D

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Severance

Seoul, Seodaemun-gu, South Korea

Seoul Natinoal Univetsity Hospital

Seoul, Seoul, South Korea

Asan Medical Center

Seoul, Seoul, South Korea

Samsung Medical Center

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

ANTG-ASC-301

Identifier Type: -

Identifier Source: org_study_id