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.
Experimental: ASC(Autologous Adipose-derived Stem Cells) and Fibringlue, Comparator: Fibringlue, Study type: Interventional, Study design: Randomized
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
46
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.
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.
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
Proportion of subjects who are completely blocked fistula
complete blockage
Time frame: In the 8th week after 1st injection
Proportion of subjects who are completely blocked fistula
complete blockage
Time frame: During 12 months after injection
Proportion of subjects who are more than 50% blocked fistula
50% blockage
Time frame: During 12 months after injection
Score of evaluation about Investigator satisfaction using questionnaire
Score of evaluation about Investigator satisfaction range from 1 to 5. The lower this score, it means that the higher investigator's satisfaction with treatment effect of investigational product.
Time frame: 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
Radiology test is performed to subjects who are completely blocked fistula.
Time frame: Between 6th month and 12th month after final injection
Visual improvement effect of perianal fistula wound through photography of it
Visual improvement effect of perianal fistula wound is evaluated by photograph of perianal fistula wound before and after the injection(intervention).
Time frame: Immediately before and after the injection(intervention) and during 12 months after injection(intervention)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.