Safety and Efficacy of Human Bone Marrow Stem Cells for Treatment of HBV-related Liver Cirrhosis

Overview

HBV related Liver disease is a common medical problem in China. An estimated 7.18% of the Chinese (about 93 million) is infected with hepatitis B, and most of the HBV- related hepatitis can developed into liver cirrhosis. Liver transplantation is the only available life saving treatment for patients with end stage liver disease. However, lack of donors, surgical complications, rejection, and high cost are serious problems. stem cells(SCs) possess plasticity and have the potential to differentiate into hepatocyte; Thus, SCs hold great hope for therapeutic applications. Adult bone marrow is the most common source of SCs for clinical applications.Previous study showed that bone marrow derived stem cells (BMSCs) replace hepatocytes in injured liver, and effectively rescue experimental liver failure and contribute to liver regeneration. In this study, the patients with HBV-related liver cirrhosis will undergo administration of human autologous BMSCs via hepatic artery to evaluate the safty and efficacy of human autologous BMSCs treatment for these patients.

Full Title of Study: “Safety and Efficacy of Human Autologous Bone Marrow Stem Cells for Treatment of HBV-related Liver Cirrhosis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2014

Interventions

  • Other: BMSC transplantation
    • Patients randomized to the intervention arm will be collected for bone marrow stem cells and then infused with these cells via hepatic artery.
  • Other: conventional treatment & antivrial treatment
    • Participants will recieve conventional treatment and antivrial treatment.

Arms, Groups and Cohorts

  • Active Comparator: conventional treatment
    • conventional treatment & antivrial treatment.
  • Experimental: BMSC transplantation
    • conventional treatment & antiviral treatment & autologous bone marrow stem cell transplantation via hepatic artery

Clinical Trial Outcome Measures

Primary Measures

  • one year survival rate
    • Time Frame: one year after treatment

Secondary Measures

  • MELD score
    • Time Frame: 1week, 4weeks, 3months, 6months, 9 months and 1year after treatment
  • AFP
    • Time Frame: 1week, 4weeks, 3months, 6months, 9 months and 1year after treatment
  • renal function
    • Time Frame: 1week, 4weeks, 3months, 6months, 9 months and 1year after treatment
  • child score
    • Time Frame: 1week, 4weeks, 3months, 6months, 9 months and 1year after treatment

Participating in This Clinical Trial

Inclusion Criteria

1. Aged 18-65 years 2. HBV-related liver cirrhosis 3. Child-Pugh score 9-15 4. Written consent Exclusion Criteria:

1. Hepatocellular carcinoma or other malignancies 2. Severe problems in other vital organs(e.g.theheart,renal or lungs) 3. Pregnant or lactating women 4. Severe bacteria infection 5. Anticipated with difficulty of follow-up observation 6. Other candidates who are judged to be not applicable to this study by doctors

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Air Force Military Medical University, China
  • Collaborator
    • The Second Affiliated Hospital of Chongqing Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Han Ying, professor – Air Force Military Medical University, China
  • Overall Official(s)
    • Daiming Fan, Study Chair, Air Force Military Medical University, China

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.