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

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

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.

Study Overview

• Status: Unknown
• Conditions: End Stage Liver Disease; Liver Cirrhosis
• Intervention / Treatment: Other: conventional treatment & antivrial treatment; Other: BMSC transplantation

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital of Digestive Disease
      • Contact: Ying Han; Phone Number: 86-29-84771539; Email: hanying@fmmu.edu.cn
      • Contact: Yongquan Shi; Phone Number: 86-29-84771515; Email: shiyquan@fmmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventional treatment; conventional treatment & antivrial treatment.	Other: conventional treatment & antivrial treatment; Participants will recieve conventional treatment and antivrial treatment.
Experimental: BMSC transplantation; conventional treatment & antiviral treatment & autologous bone marrow stem cell transplantation via hepatic artery	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
one year survival rate	one year after treatment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China
• Collaborators: Fudan University; Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Eastern Hepatobiliary Surgery Hospital; The Second Affiliated Hospital of Chongqing Medical University
• Investigators: Study Chair: Daiming Fan, Air Force Military Medical University, China

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): September 1, 2014
• Study Completion (Anticipated): September 1, 2015

Study Registration Dates

• First Submitted: October 31, 2012
• First Submitted That Met QC Criteria: November 7, 2012
• First Posted (Estimate): November 12, 2012

Study Record Updates

• Last Update Posted (Estimate): November 12, 2012
• Last Update Submitted That Met QC Criteria: November 7, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: stem cell; HBV; autologous; liver cirrhosis; end stage liver disease; bone morrow
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Pathologic Processes; Liver Diseases; End Stage Liver Disease; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: 20120912-1