NCT02786017Unknown1 期
The Safety and Efficacy Assessment of Injectable Collagen Scaffold™ Combined With Human Umbilical Cord-derived Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Patients With Decompensated Cirrhosis
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Improvement of liver function measured by change in the model for end-stage liver disease (MELD) score
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of injectable collagen scaffold combined with human umbilical cord-derived mesenchymal stem cells (HUC-MSCs) transplantation in patients with Decompensated Cirrhosis.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all of the following criteria:
- •Subjects who are decompensated cirrhosis of any cause.
- •Subjects are repeated exacerbations despite treatment and hospitalized more than once within one year because of complications of cirrhosis, (e.g., massive ascites, spontaneous bacterial peritonitis, gastrointestinal bleeding or hepatic encephalopathy).
- •Need intermittent plasma albumin and oral diuretics supplement.
- •Serum albumin <35 g/L, total bilirubin<170 μmol/L, prothrombin activity >30% (prothrombin time <20 s), moderate or mild ascites, spontaneous bacterial peritonitis and hepatic encephalopathy have been cured, Child-pugh score ≥
- •Peripheral blood hemoglobin concentration> 70g/L，platelet count > 3 × 10^9/L, hematocrit (HCT) level>0.
- •No gastrointestinal bleeding during the last one month before enrolment.
- •Patient has no conditional to undergo orthotopic liver transplantation (OLT).
- •Willing to sign informed consent.
排除标准
- •Participants CANNOT meet any of the following criteria:
- •The presence of hepatocellular carcinoma (HCC) or other malignant tumors.
- •Complicated with gastrointestinal bleeding, spontaneous bacterial peritonitis, hepatic encephalopathy, hepatorenal syndrome and acute exacerbation of infection.
- •Presence of severe comorbid diseases (e.g., severe renal, respiratory, cardiac or blood disease).
- •Pregnant or lactating women.
- •Allergy to G-CSF, contrast agents and anticoagulants.
- •Alcoholism or drug abuse.
结局指标
主要结局
Improvement of liver function measured by change in the model for end-stage liver disease (MELD) score
时间窗: 1 week, 2 week, 1, 3, 6, 12, 24 month after intervention
次要结局
- Improvement of liver function measured by change in Child-Pugh score(1 week, 2 week, 1, 3, 6, 12, 24 month after intervention)
- Change in clinical laboratory parameters of liver function(1 day, 3 day, 1 week, 2 week, 1, 3, 6, 12, 24 month after intervention)
- 30-Day Survival(30 days)
- Change in the size of liver and spleen and inner diameter of spleen portal venous(1 week, 2 week, 1, 3, 6, 12, 24 month after intervention)
研究者
Jianwu Dai
Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS
Chinese Academy of Sciences
研究点 (1)
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