Crohn's Fistula Clinical Trial
Official title:
A Phase I Dose Escalation Clinical Study of ADIPOPLUS (Autologous Cultured Adipose-derived Stem Cell) for the Treatment of Crohn's Fistula to Evaluate Safety and Efficacy
Verified date | May 2010 |
Source | Anterogen Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 9 |
Est. completion date | March 2010 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Asan medical center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Anterogen Co., Ltd. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy: closure of fistula at week 8 Safety: - Clinically measured abnormality of laboratory tests and adverse events | Yes | ||
Secondary | Closure of fistula | week 4 | ||
Secondary | Investigator satisfaction | week 4 and week 8 | ||
Secondary | Patient satisfaction | week 4 and week 8 | ||
Secondary | Digital photography | day 1, week 4 and week 8 |
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