KCT0000775招募中未知
Randomized Exploratory Clinical Trial to Evaluate the Safety and Effectiveness of Cell Transplantation Therapy using Mesenchymal Stem Cell in Alcoholic Liver Cirrhosis Patient
FCB-Pharmicell0 个研究点目标入组 72 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
- 72
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
- 20(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •(1) Histologically or clinically diagnosed as alcoholic liver cirrhosis
- •(2) Classified as Child-Pugh grade B or C
- •(3) Capable of conducting hepatic artery catheterization which inserts a catheter up to the hepatic artery
- •(4) In the case of fertile women, confirmed as negative in pregnancy test when screening, and agreed to avoid pregnancy during the trial period
- •(5) Women capable of pregnancy must satisfy the following conditions; Has been through menopause for at least 1 year, has no possibility of pregnancy via surgery/procedure, or effectively used acceptable contraceptive methods (Intrauterine device-loop, mirena, diaphragm or condom/femidom, oral contraceptive pills, non-oral contraceptives)
- •(6) Patient who can agree to participate in the clinical trial by oneself or by one's legal representative
- •(7) Able to conduct the clinical trial according to the protocol
排除标准
- •Patients who apply to at least one of the following exclusion criteria must be excluded from this clinical trial.
- •(1) Diagnosed with malignant hematologic disease (acute myeloid leukemia, acute lymphoblastic leukemia, non-Hodgkin lymphoma, Hodgkin lymphoma, multiple myeloma) and not cured from it
- •(2) Patient with severe aplastic anemia
- •(3) Has a medical record of solid cancer(within 5 years prior to screening), or diagnosed with solid cancer and currently receiving cancer treatment
- •(4) Incapable of conducting hepatic artery
- •(5) Patient who consumed alcohol and took hepatotoxic drugs within 6 months prior to registration
- •(6) Has continuously taken a large amount of steroids or antibiotics for 1 month prior to registration
- •(7) Judged by a researcher to have had major orthopedic surgery, organ biopsy, or similar external injury within 3 months prior to registration
- •(8) Evidence of active autoimmune liver disease
- •(9) Patient with extrahepatic biliary stricture
- •(10) Patient who conducted transjugular intrahepatic portosystemic shunt
- •(11) Has active thrombosis of the portal or hepatic veins
- •(12) Patient with sepsis
- •(13) Patient who suffers heart, renal, respiratory failure
- •(14) Patient who is positive in pathogenic test (HIV, Syphilis,HBV,HCV)
- •(15) Pregnant or lactating woman
- •(16) Patient who cannot adapt to the protocol and follow-up observation
- •(17) Patient who has experienced drug abuse for the past 1 year
- •(18) Participated in the other clinical trials within 30 days before registration
- •(19) Patient with any disease or condition which the investigator feel would interfere with trial or the safety of the subject
研究者
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