Mesenchymal stem cells derived from adipose tissue are pluripotent to differentiate into myocytes, adipocytes or others. They have an immunosuppressive activity. Complex perianal fistula is difficult to cure and easy to relapse. Autologous adipose stem cells have shown efficacy and safety on Crohn's fistula in phase 1 study. Based on these results, the investigators would apply autologous adipose stem cells on complex perianal fistula to evaluate their efficacy and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
15
low dose group: 1x10e7 cells/mL At 6 weeks after first stem cell injection, fistula closing was assessed. If it is not completely closed, second injection would be applied in 2 weeks. Additional dosage would be doubled to first dosage.
high dose group: 2x10e7 cells/mL At 6 weeks after first stem cell injection, fistula closing was assessed. If it is not completely closed, second injection would be applied in 2 weeks. Additional dosage would be doubled to first dosage.
Soon cheun Hyang university bucheon hospital
Bucheon-si, South Korea
Ewha womwn university mokdong hospital
Seoul, South Korea
DaeHang Hospital
Seoul, South Korea
Samsung seoul Hospital
Seoul, South Korea
Number of patients with complete closure of fistula (week 8)
Proportion of patients with completely closed fistula (week 8)
Time frame: 8 weeks
Grade of investigator's satisfaction
Grade of investigator's satisfaction (8 weeks after final dose) 1. very satisfaction 2. satisfaction 3. somewhat satisfaction 4. unsatisfaction 5. very unsatisfaction
Time frame: 8 weeks
Number of patients with closed fistula
* proportion of patients with completely closed fistula (every visits) * proportion of patients with more than 50 % closed fistula (every visits)
Time frame: 8 weeks
Photo of target fistula
Taking picture of target fistula at Day 0 and Week 4, 6, 8
Time frame: 8 weeks
Number of patients with adverse events
Number of patients with any kinds of adverse events (Day 0, every visits)
Time frame: 8 weeks
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Seoul National University Hospital
Seoul, South Korea
Seoul Saint Mary's Hospital
Seoul, South Korea