Therapeutic Effects of Liver Failure Patients Caused by Chronic Hepatitis B After Autologous MSCs Transplantation
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ClinicalTrials.gov Identifier: NCT00956891 |
Recruitment Status
:
Completed
First Posted
: August 11, 2009
Last Update Posted
: December 7, 2010
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Condition or disease |
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Liver Failure Mesenchymal Stem Cells |
Study Type : | Observational |
Actual Enrollment : | 158 participants |
Observational Model: | Case Control |
Time Perspective: | Retrospective |
Official Title: | Therapeutic Effects Including Short-term Changes And Long-term Outcomes of Liver Failure Patients Caused by Chronic Hepatitis B After Single Transplantation With Autologous Bone Marrow Mesenchymal Stem Cells. |
Study Start Date : | May 2005 |
Actual Primary Completion Date : | June 2009 |
Actual Study Completion Date : | July 2010 |
Group/Cohort |
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group A
autologous MSCs transplantation were performed plus medical treatments (reducibility glutathione, glycyrrhizin, ademetionine, polyene phosphatidylcholine, alprostadil, and human serum albumin)
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group B
only medical treatments (reducibility glutathione, glycyrrhizin, ademetionine, polyene phosphatidylcholine, alprostadil, and human serum albumin) were performed without autologous MSCs transplantation.
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- Short-term therapeutic effects of transplantation. [ Time Frame: 1 to 4 weeks after transplantation ]Biochemical indexes [alanine aminotransferase (ALT), albumin (ALB), total bilirubin (TBIL), prothrombin time (PT) and Model for End-stage Liver Disease (MELD) ] were compared 1 to 4 weeks after transplantation.
- Long-term outcomes of transplantation. [ Time Frame: 3 ~ 48 months years after transplantation ]In 3 ~ 48 months of follow-up, incidence of HCC (hepatocellular carcinoma) and mortality were compared between two groups.

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Ages Eligible for Study: | 15 Years to 70 Years (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Liver failure
Exclusion Criteria:
- HBV negative

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): NCT00956891
China, Guangdong | |
The Third Affiliated Hospital Of Sun Yat-sen University | |
Guangzhou, Guangdong, China, 510630 |
Study Director: | Zhi-liang Gao, Dr | Department of Infectious Diseases, 3rd Affiliated Hospital of Sun Yat-sen University, China |
Responsible Party: | The Third Affliated Hospital of Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT00956891 History of Changes |
Other Study ID Numbers: |
SunYat-senU 5010 hepatitisB |
First Posted: | August 11, 2009 Key Record Dates |
Last Update Posted: | December 7, 2010 |
Last Verified: | August 2009 |
Keywords provided by Sun Yat-sen University:
short-term effects long-term follow-up liver failure patients autologous MSCs transplantation |
Additional relevant MeSH terms:
Hepatitis, Chronic Hepatitis B Hepatitis B, Chronic Liver Failure Hepatitis Liver Diseases Digestive System Diseases Hepadnaviridae Infections DNA Virus Infections |
Virus Diseases Hepatitis, Viral, Human Hepatic Insufficiency Polyene phosphatidylcholine Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents |