Crohn's Fistula
Conditions
Brief summary
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.
Interventions
BIOLOGICALADIPOPLUS
autologous cultured adipose-derived stem cells 1x10e7 cells/1cm2 depending on surface area of fistula
Sponsors
Anterogen Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Older than 18 years * Prior diagnosis of Crohn's disease * patients who have Crohn's fistula * negative for serum beta-HCG for woman of childbearing age * agreement to participate, with signed informed-consent
Exclusion criteria
* patients who have allergy to bovine-derived materials or an anesthetic * patients with a diagnosis of auto immune disease except for Crohn's disease * Diagnosis of HBV, HCV, HIV and other infectious disease * Patients who have a symptom of septicemia * Patients with a diagnosis of active Tuberculosis * Patient who are pregnant or breast-feeding * Patients who are unwilling to use an effective method of contraception during the study * Patients with a diagnosis of Inflammatory Bowel Disease except for Crohn's disease * Patients who are sensitive to Fibrin glue * Patients who have a clinically relevant history of abuse of alcohol or drugs, habitual smoker * Insufficient adipose tissue for manufacturing of ADIPOPLUS * Patients who are considered not suitable for the study by investigator * Patients with a diagnosis of active refractory Crohn's disease * Patients who have history of surgery for malignant cancer in the past 5 years * Patients who have \> 2 cm diameter of fistula
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: complete closure of fistula at week 8 | 8 weeks |
| number of patients with any adverse event | Day 0, Week 8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Photo of target fistula | 8 weeks | taking Photo of target fistula : Day 0, week 4, 6, 8 |
| number of patients with any adverse events | 8 weeks | Adverse reaction : day 0, Week 4, 6, 8 |
| number of patients with complete closure of fistula | 8 weeks | complete closure : every visits more than 50% closure of fistula : every visits |
| Investigator's satisfaction | 8 weeks | Investigator's satisfaction : week 8 |
Countries
South Korea
Outcome results
None listed