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

Anterogen

Status and phase: Active, not recruiting; Phase 3

Conditions: Crohn's Fistula

Treatments: Drug: Fibringlue; Biological: ASC

Study type: Interventional

Funder types: Industry

Identifiers

NCT04612465

ANTG-ASC-301

Details and patient eligibility

About

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.

Full description

Experimental: ASC(Autologous Adipose-derived Stem Cells) and Fibringlue, Comparator: Fibringlue, Study type: Interventional, Study design: Randomized

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups, including a placebo group

ASC (test arm)

Experimental group

Description:

(Autologous Adipose-derived Mesenchymal Stem Cells)

Treatment:

Biological: ASC

Fibringlue

Placebo Comparator group

Description:

Standard comparator

Treatment:

Drug: Fibringlue