KCT0000188Recruiting未知
A Phase I dose escalation clinical study to evaluate the safety and efficacy of ALLO-ASC(Allogenic adipose-derived stem cells) in the patients with Crohn's fistula.
Anterogen0 sites6 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Enrollment
- 6
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 18(Year) to 60(Year) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
- •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
Investigators
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