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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

January 9, 2020

Primary Completion Date

April 8, 2025

Study Completion Date

September 23, 2025

Conditions
Crohn's Fistula
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.

Trial Locations (4)

03722

Severance, Seoul

03080

Seoul Natinoal Univetsity Hospital, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

All Listed Sponsors
lead

Anterogen Co., Ltd.

INDUSTRY

NCT04612465 - Clinical Study to Evaluate Efficacy and Safety of ASC and Fibringlue or Fibringlue in Patients With Crohn's Fistula | Biotech Hunter | Biotech Hunter