A Phase I clinical study to evaluate the safety and efficacy of allogenic adipose-derived stem cells in the patients with Crohn's fiatula.
- Conditions
- Symptoms, signs and abnormal clinical and laboratory findings, NEC
- Registration Number
- KCT0000188
- Lead Sponsor
- Anterogen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 6
1. Age 18~60 years old
2. Diagnosed with Crohn's disease
3. Crohn's fistula which has been lasted at least for 3 months
4. If a patient is taking aminosalicylate, corticosteroid, methotrexate, azathioprine, antibiotics or mercaptopurine, those dosages should be stabilized at least 8 weeks before screening. If a patient had been taking those medications but not now, he should have stopped at least 4 weeks before visit.
5. Negative for beta-HCG pregnancy test
6. Who can submit a written consent form and is obliged to Clinical Trial Protocol.
1. Who has been participated in other clinical trials within 30 days or does not passed at least 5 times period of half-life of other investigational drugs.
2. Medical history with Variant Creutzfeld Jacobs Disease
3. Allergic to anesthetics or bovine protein
4. Autoimmune disease other than Crohn's disease
5. Infectious disease such as HBV, HCV or HIV
6. Sepsis
7. active tuberculosis
8. pregnant or breast feeding woman
9. who is not willing to use effective contraceptive methods.
10. Inflammatory Bowel disease other than Crohn's disease
11. Allergic to fibrin glue
12. Who has a history of alcohol or drug abuse or habitual smoking
13. active crohn's disease with CDAI score > 200
14. surgical history of malignant tumor within 5 years (except carcinoma in situ)
15. diagnosed with malignant tumor
16. fistula's diameter > 2 cm
17. who has experienced with cyclosporine or infliximab in 3 months before screening
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety(laboratory hematology, adverse effects, immunological response, tolerance);Proportion of patients with completely healing
- Secondary Outcome Measures
Name Time Method Proportion of patients with more than 50% healed fistula;Sustained safety and efficacy(recurrence or adverse effects)