A Phase 3 interventional study of autologous bone marrow mesenchymal stem cells transplantation and autologous bone marrow msenchymal stem cells transplantation in Immune Function in Blood, Liver Function in Blood and Variation of Ascites, sponsored by Nanjing PLA General Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-05-15.
Sponsored by Nanjing PLA General Hospital · Phase 3, Interventional, and Treatment
Liver cirrhosis (LC) is the final destiny in chronic liver disease.The quality of life in liver cirrhosis patients with refractory ascites are very wretched. The objective of this study is to evaluate the therapeutic efficacy of autologous bone marrow mesenchymal stem cells (BMSCs) transplantation via liver artery in Child-Pugh B and C stage of liver cirrhosis patients with refractory ascites. The immunomodulatory impact of MSCs in fibrosis was confirmed, and several clinical studies have applied MSCs to eliminate the progression of fibrosis. In this research the investigators will study the affect and influence of MSCs in the patients,include assay of liver function,variation of ascites,Child-Pugh score etc.
252 studies on the registry are indexed under Ascites; 52 are open to participants now.
This study's planned enrollment of 30 is below the median of 55 across 177 interventional studies indexed under Ascites.
Browse Ascites studies →Nanjing PLA General Hospital is the lead sponsor of 17 studies on the registry; none are open to participants now.
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Inclusion Criteria:Inclusion Criteria:
Aged 18\~65 years. Ultrasonographic evidences of cirrhosis. hepatic cirrhosis patients with refractory ascite.
Exclusion Criteria:
history of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrolment.
Prothrombin time is less than 30s. Severe problems in other vital organs(e.g.the heart,renal or lungs). Liver tumor on ultrasonography, CT or MRI examination. Pregnant or lactating women. Imaging evidences of vascular thromboses.
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Exclusion Criteria:
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Every patient is given 1x106 MSCs per kg infused via liver artery
Biological: autologous bone marrow mesenchymal stem cells transplantation · Biological: autologous bone marrow msenchymal stem cells transplantation
autologous bone marrow mesenchymal stem cells transplantation
Biological: autologous bone marrow mesenchymal stem cells transplantation · Biological: autologous bone marrow msenchymal stem cells transplantation
autologous bone marrow mesenchymal stem cells transplantation
Biological: autologous bone marrow mesenchymal stem cells transplantation · Biological: autologous bone marrow msenchymal stem cells transplantation
Autologous MSCs were infused to patients using interventional method via hepatic artery . The catheter was inserted to proper hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography, autologous bone marrow MSCs were infused slowly for 20-30 minutes.
change in immune function,liver function in blood
Time frame: before and one to 12 weeks after therapy
This study is status unknown, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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Nanjing PLA General Hospital