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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Up to date, a sure cure for Crohn's fistula has not known and the fistula recurrence rate is high. On 15 October 2008, orphan drug designation was granted by Korea FDA to Anterogen Co. Ltd., for human adipose-derived stem cell. In this study, patients are given injection of ADIPOPLUS in fistula site and followed for 8 weeks to test the safety and efficacy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anterogen Co., Ltd.

Criteria

Inclusion Criteria:

• Older than 18 years

• Prior diagnosis of Crohn's disease

• patients who have Crohn's fistula

• negative for urine 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

• Patients 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 is sensitive to Fibrin glue

• Patients who have a clinically relevant history of abuse of alcohol or drugs

• Insufficient adipose tissue for manufacturing of ADIPOPLUS

• Patients who are considered not suitable for the study by investigator

• Patients who have history of surgery for malignant cancer in the past 5 years