Complex Perianal Fistula
Conditions
Keywords
crohn's disease, fistula, complex
Brief summary
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.
Interventions
BIOLOGICALAutologous cultured adipose derived stem cells(low dose group)
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.
BIOLOGICALAutologous cultured adipose derived stem cells(high dose group)
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.
Sponsors
Anterogen Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* a patient who has complex perianal fistula * a patient who is negative in pregnancy test * a patient who has submitted a written consent
Exclusion criteria
* a patient who has participated in other clinical studies within 30 days before this clinical trial or has not passed 5 fold period of a half-life of other investigational drugs. * a patient who has a history of variant Creutzfeldt Jacobs disease or related diseases * a patient who is allergic to anesthetics, bovine derived proteins or a fibrin glue * a patient who has an autoimmune disease * a patient who has infectious diseases such as hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) * a patient who has sepsis or active tuberculosis * a patient who is pregnant or breast feeding * a patient who has inflammatory Bowel disease * over 2cm in diameter of fistula
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with complete closure of fistula (week 8) | 8 weeks | Proportion of patients with completely closed fistula (week 8) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grade of investigator's satisfaction | 8 weeks | Grade of investigator's satisfaction (8 weeks after final dose) 1. very satisfaction 2. satisfaction 3. somewhat satisfaction 4. unsatisfaction 5. very unsatisfaction |
| Number of patients with closed fistula | 8 weeks | * proportion of patients with completely closed fistula (every visits) * proportion of patients with more than 50 % closed fistula (every visits) |
| Photo of target fistula | 8 weeks | Taking picture of target fistula at Day 0 and Week 4, 6, 8 |
| Number of patients with adverse events | 8 weeks | Number of patients with any kinds of adverse events (Day 0, every visits) |
Countries
South Korea
Outcome results
None listed