Adipose-derived stem cells have properties of differentiation to various types of cells, immunomodulatory effects. adipose-derived stem cells (ASCs) show also low immunogenicity. Anterogen has developed ANTG-ASC(Autologous ASC) which has shown good efficacy and safety in Phase I and II study on the patients with Crohn's fistula. However, Crohn's patients are sometimes not fat enough to extract fat tissue for culturing ASCs. Therefore the investigators have planned to study allogenic ASCs for safety and efficacy in patients with Crohn's fistula.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
ALLO-ASC 1xE7 cells/mL is injected once along the fistula. If there is no safety issue for 4 weeks, 3 more people could be enrolled who are subject to ALLO-ASC 3xE7 cells/mL.
Keonghee Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Yeonsei Medical Center
Seoul, South Korea
General safety (Laboratory screening, adverse effects, immunological response, local tolerance)
Time frame: Week8
Proportion of patients with sustained efficacy
Proportion of patients with more than 50% healed fistula at Month 8 Following up whether there is a recurrence at Month 8
Time frame: Month 8
Proportion of patients with adverse effects
Evaluate the safety at 8 months whether any kind of AE occurs.
Time frame: at month 8
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