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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Crohn's Fistula

Intervention / Treatment
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* Biological: ADIPOPLUS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADIPOPLUS<br>patients with a fistula in Crohn's disease | Biological: ADIPOPLUS<br>* autologous cultured adipose-derived stem cells 1x10e7 cells/1cm2 depending on surface area of fistula<br>* Other names: ANTG-ASC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: complete closure of fistula at week 8 |  | 8 weeks | 
| number of patients with any adverse event |  | Day 0, Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photo of target fistula | taking Photo of target fistula : Day 0, week 4, 6, 8 | 8 weeks | 
| number of patients with any adverse events | Adverse reaction : day 0, Week 4, 6, 8 | 8 weeks | 
| number of patients with complete closure of fistula | complete closure : every visits more than 50% closure of fistula : every visits | 8 weeks | 
| Investigator's satisfaction | Investigator's satisfaction : week 8 | 8 weeks |