Therapeutic Effects of Liver Failure Patients Caused by Chronic Hepatitis B After Autologous MSCs Transplantation

This study has been completed.
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00956891
First received: August 10, 2009
Last updated: December 6, 2010
Last verified: August 2009
  Purpose

The study aimed to investigate the short-term efficacy and long-term prognosis of liver failure patients caused by hepatitis B after single transplantation with autologous marrow mesenchymal stem cells (MMSCs). Liver failure inpatients caused by hepatitis B were recruited and received the same medical treatments, among whom some patients underwent single transplantation with autologous MMSCs and other patients with matched age, gender and biochemical indexes [alanine aminotransferase (ALT), albumin (ALB), total bilirubin (TBIL), prothrombin time (PT) and Model for End-stage Liver Disease (MELD) ] were in control group. A total of 120 ml bone marrow were obtained from patients, diluted and separated. Then MMSCs suspension were slowly transfused into the liver through the proper hepatic artery by interventional procedures. The levels of ALB, TBIL, PT and MELD score of patients in translation group were compared with those in control group. In 3 ~ 48 months of follow-up, differences in long-term outcomes such as incidence of HCC (hepatocellular carcinoma) and mortality between two groups were compared.


Condition Phase
Liver Failure
Mesenchymal Stem Cells
Phase 1
Phase 2

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Short-term therapeutic effects of transplantation. [ Time Frame: 1 to 4 weeks after transplantation ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Long-term outcomes of transplantation. [ Time Frame: 3 ~ 48 months years after transplantation ] [ Designated as safety issue: Yes ]
    In 3 ~ 48 months of follow-up, incidence of HCC (hepatocellular carcinoma) and mortality were compared between two groups.


Enrollment: 158
Study Start Date: May 2005
Study Completion Date: July 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
group A
autologous MSCs transplantation were performed plus medical treatments (reducibility glutathione, glycyrrhizin, ademetionine, polyene phosphatidylcholine, alprostadil, and human serum albumin)
group B
only medical treatments (reducibility glutathione, glycyrrhizin, ademetionine, polyene phosphatidylcholine, alprostadil, and human serum albumin) were performed without autologous MSCs transplantation.

Detailed Description:

A total of 527 patients with chronic hepatitis B induced liver failure were recruited from May 2005 to June 2009 from our department. The diagnoses of chronic hepatitis B and liver failure were based on previously described criteria. All patients received the same medical treatments (reducibility glutathione, glycyrrhizin, ademetionine, polyene phosphatidylcholine, alprostadil, and human serum albumin). Informed consent was obtained before study. Among these patients, 53 received transplantation with autologous MMSCs. The day of surgery served as the first day of observation. And 105 patients with matched age, gender and some biochemical indexes (ALT, ALB, TBIL, PT and MELD ) were served as controls.

  Eligibility

Ages Eligible for Study:   15 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Liver failure patients with HBV infection

Criteria

Inclusion Criteria:

  • Liver failure

Exclusion Criteria:

  • HBV negative
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00956891

Locations
China, Guangdong
The Third Affiliated Hospital Of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Study Director: Zhi-liang Gao, Dr Department of Infectious Diseases, 3rd Affiliated Hospital of Sun Yat-sen University, China
  More Information

No publications provided

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
Study First Received: August 10, 2009
Last Updated: December 6, 2010
Health Authority: United States: Institutional Review Board
China: Food and Drug Administration

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 B, Chronic
Hepatitis, Chronic
Hepatitis B
Liver Failure
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatic Insufficiency
Polyene phosphatidylcholine
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014