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临床试验/KCT0000188
KCT0000188招募中未知

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 个研究点目标入组 6 人开始时间: 待定最近更新:
适应症

试验速览

阶段
未知
状态
招募中
发起方
入组人数
6

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional Study

入排标准

年龄范围
18(Year) 至 60(Year)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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

研究者

发起方
Anterogen

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