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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: June 2009

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.

Arms, Groups and 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Liver failure Exclusion Criteria:

  • HBV negative

Gender Eligibility: All

Minimum Age: 15 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sun Yat-sen University
  • Provider of Information About this Clinical Study
    • The Third Affliated Hospital of Sun Yat-sen University, The Third Affliated Hospital of Sun Yat-sen University
  • Overall Official(s)
    • Zhi-liang Gao, Dr, Study Director, Department of Infectious Diseases, 3rd Affiliated Hospital of Sun Yat-sen University, China

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