Randomized Exploratory Clinical Trial to Evaluate the Safety and Effectiveness of Stem Cell Product in Alcoholic Liver Cirrhosis Patient.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Histopathological evaluation (Fibrosis Grade - Laennec Scoring System)
研究概览
简要总结
If the participant voluntarily agrees to participate in the clinical trial before registration, the investigator conducts a screening test to evaluate the participant's suitability.
A participant that satisfies all selection and exclusion criteria is assigned randomly to a test group (1-time or 2-time injection group) or control group (no-cell therapy group). Participants assigned to the 1-time injection group conduct cell therapy within 1 month after bone marrow aspiration. Before implementing cell therapy, implement hepatic artery catheterization which inserts a catheter into the hepatic artery through the right aorta femoralis and inject 5X107 autologous bone marrow-derived mesenchymal stem cells. Participants assigned to the 2-time injection group store 1-time injection amount of mesenchymal stem cells while being cultivated after sampled from the bone marrow, and will re-inject autologous mesenchymal stem cells within 1 month after first injection.
Participants will make a total of 8 hospital visits on a 4-week interval after registration, and effectiveness and safety will be evaluated based on a fixed procedure on every visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or clinically diagnosed as alcoholic liver cirrhosis
- •Classified as Child-Pugh grade B or C
- •Age of 20 ~ 70 years
- •Capable of conducting hepatic artery catheterization which inserts a catheter up to the hepatic artery
- •In the case of fertile women, confirmed as negative in pregnancy test when screening, and agreed to avoid pregnancy during the trial period
- •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)
- •Patient who can agree to participate in the clinical trial by oneself or by one's legal representative
- •Able to conduct the clinical trial according to the protocol
排除标准
- •Diagnosed with malignant hematologic disease (acute myeloid leukemia, acute lymphoblastic leukemia, non-Hodgkin lymphoma, Hodgkin lymphoma, multiple myeloma) and not cured from it
- •Patient with severe aplastic anemia
- •Has a medical record of solid cancer(within 5 years prior to screening), or diagnosed with solid cancer and currently receiving cancer treatment
- •Incapable of conducting hepatic artery
- •Patient who consumed alcohol and took hepatotoxic drugs within 6 months prior to registration
- •Has continuously taken a large amount of steroids or antibiotics for 1 month prior to registration
- •Judged by a researcher to have had major orthopedic surgery, organ biopsy, or similar external injury within 3 months prior to registration
- •Evidence of active autoimmune liver disease
- •Patient with extrahepatic biliary stricture
- •Patient who conducted transjugular intrahepatic portosystemic shunt
- •Has active thrombosis of the portal or hepatic veins
- •Patient with sepsis
- •Patient who suffers heart, renal, respiratory failure
- •Patient who is positive in pathogenic test (HIV, Syphilis,HBV,HCV)
- •Pregnant or lactating woman
- •Patient who cannot adapt to the protocol and follow-up observation
- •Patient who has experienced drug abuse for the past 1 year
- •Participated in the other clinical trials within 30 days before registration
- •Patient with any disease or condition which the investigator feel would interfere with trial or the safety of the subject
研究组 & 干预措施
Control group
Best Supportive care
2-time injection group: Livercellgram
Within 1 month after extracting bone marrow, directly inject 5X107 autologous bone marrow-derived mesenchymal stem cells within liver through the hepatic artery. Within 1 month after cell injection, re-inject autologous bone marrow-derived mesenchymal stem cells.
干预措施: Livercellgram (Biological)
1-time injection group: Livercellgram
Within 1 month after extracting bone marrow, directly inject 5X107 autologous bone marrow-derived mesenchymal stem cells within liver through the hepatic artery.
干预措施: Livercellgram (Biological)
结局指标
主要结局
Histopathological evaluation (Fibrosis Grade - Laennec Scoring System)
时间窗: 6 month after cell therapy
次要结局
- Histopathological evaluation score (Ratio of 1-time injection group to 2-time injection group comparison)(6month)
- MELD Score(6month)
- Child-Pugh grade(6month)
- Liver Function Test (ALT, AST, ALP, Albumin, billirubin, r-GT)(6month)
- Visual Inspection (Liver volume, Fibroscan)(6month)