Bone Mesenchymal Stem Cell (BMSC) Transplantation in Liver Cirrhosis Via Portal Vein
This trial is active, not recruiting.
|Treatments||autologous bmscs transplantation, conserved therapy|
|Sponsor||Sun Yat-sen University|
|Start date||October 2009|
|End date||October 2010|
|Trial size||60 participants|
|Trial identifier||NCT00993941, 1-Bingliang|
The objective of this study is to evaluate the therapeutic efficacy of autologous bone marrow mesenchymal stem cells (BMSCs) transplantation via portal vein in patients with early and middle stage of liver cirrhosis on the basis of HBV infection. The evaluation of the efficacy includes the level of serum alanine aminotransferase (ALT), aspartate aminotransferase(AST), total bilirubin (TB),prothrombin time (PT), albumin (ALB), prealbumin(PA), precollagenⅢ(PCⅢ), collagenⅣ(Ⅳ-C), laminin(LN), hyaluronidase(HN), liver histological improvement before and 1 week to 1 year after transplantation. Child-Pugh scores and clinical symptoms were also observed simultaneously.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
The levels of serum alanine aminotransferase (ALT), total bilirubin (TB),prothrombin time (PT), albumin (ALB), prealbumin(PA), precollagenⅢ(PCⅢ), collagenⅣ(Ⅳ-C), laminin(LN), hyaluronidase(HN), liver histological improvement.
time frame: pre-transplantation, and 1week to 1 year post-transplantation
Male or female participants from 18 years up to 60 years old.
Inclusion Criteria: - Aged 18~60 years. - Serum HBsAg positive. - Ultrasonographic evidences of cirrhosis. 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. - Cirrhosis caused by other reasons except HBV infection. - 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.
|Official title||Evaluation the Efficacy and Safety of Autologous Bone Marrow Mesenchymal Stem Cells (MSCs) Transplantation in Patients With Early and Middle Stage of Liver Cirrhosis|
|Principal investigator||Lin B liang, MD/PHD|
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