Up to date, a sure cure for Crohn's fistula does not known and the fistula recurrence rate is high. On 15 October 2008, orphan designation was granted by Korea FDA for human adipose-derived stem cell (ADIPOPLUS) for the treatment of Crohn's fistula. In this study, patients are given injection of ADIPOPLUS in fistula site and followed for 8 weeks to evaluate the safety and efficacy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
autologous cultured adipose-derived stem cells 1x10e7 cells/1cm2 depending on surface area of fistula
Asan medical center
Seoul, South Korea
Efficacy: complete closure of fistula at week 8
Time frame: 8 weeks
number of patients with any adverse event
Time frame: Day 0, Week 8
Photo of target fistula
taking Photo of target fistula : Day 0, week 4, 6, 8
Time frame: 8 weeks
number of patients with any adverse events
Adverse reaction : day 0, Week 4, 6, 8
Time frame: 8 weeks
number of patients with complete closure of fistula
complete closure : every visits more than 50% closure of fistula : every visits
Time frame: 8 weeks
Investigator's satisfaction
Investigator's satisfaction : week 8
Time frame: 8 weeks
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