Bone Mesenchymal Stem Cell (BMSC) Transplantation in Liver Cirrhosis Via Portal Vein
|ClinicalTrials.gov Identifier: NCT00993941|
Recruitment Status : Unknown
Verified October 2009 by Sun Yat-sen University.
Recruitment status was: Active, not recruiting
First Posted : October 14, 2009
Last Update Posted : December 6, 2010
|Condition or disease||Intervention/treatment||Phase|
|Liver Cirrhosis||Procedure: Autologous BMSCs transplantation Drug: Conserved therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2009|
|Estimated Primary Completion Date :||October 2010|
|Estimated Study Completion Date :||April 2011|
Active Comparator: Group A(conserved therapy )
Thirty of the enrolled patients were randomly assigned to Group A were received comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.
Drug: Conserved therapy
Oral or intravenous administration
Experimental: Group B (BMSC Transplantion)
Thirty of the enrolled patients were randomly assigned to Group B were received comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine, as well as Bone Mesenchymal Stem Cells(BMSC) transplantation via portal vein.
Procedure: Autologous BMSCs transplantation
10 ml autologous BMSCs(7~8log10 cells/ml) were infused to patients using interventional method via portal vein as well as conserved therapy for group B.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00993941
|Sun Yat-sen University|
|Guangzhou, Guangdong, China|
|Principal Investigator:||Lin B liang, MD/PHD||SunYat-sen University|