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Clinical Study to Evaluate Efficacy and Safety of ASC and Fibringlue or Fibringlue in Patients With Crohn's Fistula
Sponsor: Anterogen Co., Ltd.
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
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.
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