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ACTIVE NOT RECRUITING
NCT04612465
PHASE3

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

Sponsor: Anterogen Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2020-01-09

Completion Date

2025-09-23

Last Updated

2025-09-29

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

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.

DRUG

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.

Locations (4)

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