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 个研究点目标入组 6 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

暂无简介。

•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
•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

发起方

Anterogen