Autologous Bone Marrow Mesenchymal Stem Cells Transplantation Via Hepatic Artery in Patients With Liver Cirrhosis
This trial is active, not recruiting.
|Treatments||hepatic artery infusion, conserved therapy|
|Sponsor||Sun Yat-sen University|
|Collaborator||Third Affiliated Hospital, Sun Yat-Sen University|
|Start date||January 2008|
|End date||December 2009|
|Trial size||50 participants|
|Trial identifier||NCT00976287, zssy|
The purpose of this study is to investigate the efficacy of autologous bone marrow mesenchymal stem cells (MSCs) transplantation via hepatic artery in the treatment of liver cirrhosis. Liver function was monitored by serum examination. The levels of serum alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT) and albumin (ALB) were examined at pre-transplantation, and 3 days to 2 years post-transplantation. Child-Pugh scores and clinical symptoms were also observed simultaneously.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
The levels of serum alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT), albumin (ALB)
time frame: pre-transplantation, and 3 days to 2 years post-transplantation
Male or female participants from 18 years up to 70 years old.
Inclusion Criteria: - Age 18-70 years. - Imaging evidences of liver cirrhosis. - Child-Plough score of 10 or more. Exclusion Criteria: - Liver tumor on ultrasonography, CT or MRI examination. - Problems in organs other than the liver(e.g.the heart or lungs). - History of moderate to severe hepatic encephalopathy or variceal bleeding. - Imaging evidences of vascular thromboses. - Coma.
|Official title||Autologous Bone Marrow Mesenchymal Stem Cells Transplantation Via Hepatic Artery in Patients With Liver Cirrhosis|
|Description||Patients with liver cirrhosis were randomly separated into two groups. Autologous MSCs were infused to patients using interventional method via hepatic artery for One group. 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. The control group accepted conserved therapy.|
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