NCT04612465.

Study name	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
Methods	Phase III RCT, Open Label, Parallel Assignment
Participants	36 Patient who has one or more Crohn's fistulas. 18 Years and older
Interventions	Experimental: ASC (Autologous Adipose‐derived Mesenchymal Stem Cells) 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. Standard Comparator (control): Fibringlu
Outcomes	Primary outcome: Proportion of subjects who are completely blocked fistula [ Time Frame: In the 8th week after 1st injection ] ; complete blockage
Starting date	January 9, 2020
Contact information	Contact: KyuJoo Park, MD. Ph D+82‐02‐2072‐2901 mailto:kjparkmd%40plaza.snu.ac.kr?subject=NCT04612465, ANTG‐ASC‐301, Clinical Study to Evaluate Efficacy and Safety of ASC and Fibringlue or Fibringlue in Patients With Crohn's Fistula
Notes	estimated study completion date: December 31, 2021 Locations for recruitments: 1‐ Seoul Natinoal Univetsity Hospital 2‐ Asan Medical Center 3‐ Samsung Medical Center Sponsors: Anterogen Co., Ltd.

ATG: anti‐thymocyte globulin; CD: Crohn'sdisease; IMP: Investigational Medicinal Product; G‐CSF: granulocyte‐colony stimulating factor; MRI: magnetic resonance imaging