Bone Mesenchymal Stem Cell (BMSC) Transplantation in Liver Cirrhosis Via Portal Vein
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|