Autologous Transplantation of Bone Marrow Derived CD 133 Positive Stem Cell and Mono Nuclear Cell (MNC) Transplantation in Patients With Decompensate Cirrhosis: Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 3
- 主要终点
- Liver function test
研究概览
简要总结
Liver cirrhosis (LC) is the end stage of chronic liver disease. The liver transplantation is one of the only effective therapies available to such patients. However, lack of donors, surgical complications, rejection, and high cost are it's serious problems. The potential for stem cells in bone marrow (BM) to differentiate into hepatocytes cells was recently confirmed. Moreover, BMC transplantation has been performed to treat hematological diseases, and several clinical studies have applied BMC injection to induce regeneration of myocardium and blood vessels. In this study we will evaluate safety and feasibility of autologous bone marrow mono nuclear (BM-MNC) and enriched CD133+ hematopoietic stem cell transplantation through the portal vein in patients with decompensate cirrhosis.
详细描述
BM (200 ml) will be harvested from the iliac crest according to standard procedures under general anesthesia and is collected in plastic bags containing anti coagulant. After precipitation of red blood cells, Low density mononuclear cells will be collected by centrifugation in Ficoll-Paque density gradient. For CD133+ cells separation the CliniMACS instrument will be used. Cells are injected via portal vein under sonography monitoring. After cell therapy, patients are followed up every week for 4 weeks, and laboratory data are analyzed for 24 weeks.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver biopsy showing histological Cirrhosis, grade B or C (Child-Pugh score)
- •Alkaline phosphatase between 2 X to 3X normal value
- •liver Cirrhosis in Sonography study
- •Incomplete response to UDCA after 6 months of treatment.
- •Negative pregnancy test (female patients in fertile age)
- •written consent
排除标准
- •Presence of active hepatic encephalopathy
- •Refractory ascites
- •Evidences of active autoimmune liver disease (e.g. gamma globulin of more than 2 times of upper limit of normal, and ALT > 3 times normal in patients with autoimmune hepatitis)
- •Hepatocellular carcinoma or other malignancies
- •Presence of significant extrahepatic biliary disease (e.g. CBD stone, PSC, etc.)
- •HIV, HBV or HCV infection
- •Cardiac, renal or respiratory failure
- •Active thrombosis of the portal or hepatic veins
结局指标
主要结局
Liver function test
时间窗: 6 months
MELD score
时间窗: 6 months
次要结局
- Cirrhosis mortality(6 months)