Safety and Efficacy Study of Autologous Cultured Adipose -Derived Stem Cells for the Crohn's Fistula

A Phase II Clinical Study of ADIPOPLUS (Autologous Cultured Adipose-derived Stem Cell) for the Treatment of Crohn's Fistula to Evaluate Safety and Efficacy

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.

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