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

NCT04612465 | Active Not Recruiting Phase 3

• 1 other identifier: ANTG-ASC-301
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 4

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.

Conditions

Crohn's Fistula

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects who are completely blocked fistula

  complete blockage

  In the 8th week after 1st injection

Secondary Outcomes (5)

• Proportion of subjects who are completely blocked fistula

  During 12 months after injection

• Proportion of subjects who are more than 50% blocked fistula

  During 12 months after injection

• Score of evaluation about Investigator satisfaction using questionnaire

  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

  Between 6th month and 12th month after final injection

• Visual improvement effect of perianal fistula wound through photography of it

  Immediately before and after the injection(intervention) and during 12 months after injection(intervention)

Study Arms (2)

ASC (test arm)

EXPERIMENTAL

(Autologous Adipose-derived Mesenchymal Stem Cells)

Biological: ASC

Fibringlue

PLACEBO COMPARATOR

Standard comparator

Drug: Fibringlue

Interventions

ASC 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.

Also known as: (Autologous Adipose-derived Mesenchymal Stem Cells)

ASC (test arm)

Fibringlue 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.

Also known as: standard control

Fibringlue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anterogen Co., Ltd.: lead

Study Sites (4)

Severance

Seoul, Seodaemun-gu, 03722, South Korea

Location

Seoul Natinoal Univetsity Hospital

Seoul, Seoul, 03080, South Korea

Location

Asan Medical Center

Seoul, Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, Seoul, 06351, South Korea

Location

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: November 3, 2020
• Study Start: January 9, 2020
• Primary Completion: April 8, 2025
• Study Completion: September 23, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

KR (4)