Status:
COMPLETED
Safety and Efficacy Study of Autologous Cultured Adipose -Derived Stem Cells for the Crohn's Fistula
Lead Sponsor:
Anterogen Co., Ltd.
Conditions:
Crohn's Fistula
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00992485
Start Date
November 1 2008
End Date
March 1 2010
Last Update
May 10 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Asan medical center
Seoul, South Korea, 138-736