Safety and Efficacy of Human Autologous Peripheral Blood 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.

In preclinical studies the investigators have demonstrated that G-CSF mobilized PBSC from patients with HBV related liver cirrhosis could differentiate into functional hepatocyte and autologous PBSC transplantation can significantly improve liver synthetic function. But further studied was needed to confirm the safety and efficacy of PBSC transplantation. In this study, a prospective, randomized, parallel clinical study was designed. The patients with HBV-related liver cirrhosis will undergo administration of human autologous PBSCs via hepatic artery to evaluate the safety and efficacy of human autologous PBSCs treatment for these patients.

Study Overview

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

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

Contacts and Locations

• Study Contact: Name: Ying Han; Phone Number: 86-29-84771539; Email: hanying@fmmu.edu.cn
• Study Contact Backup: Name: Yongquan Shi; Phone Number: 86-29-84771515; Email: shiyquan@fmmu.edu.cn

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.the heart,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; conventional treatment & antiviral treatment	Other: conventional treatment; Participants will receive conventional treatment and antiviral treatment.
Experimental: conventional & PBSC transplantation; After three days G-CSF mobilization, Patients randomized to the intervention arm will receive autologous PBSCs transplantation at day1, and receive conventional treatment and antiviral treatment through the one year study visit and followed until one years study visit.	Other: PBSC transplantation; PBSCs were mobilized with recombinant human G-CSF at 5-10ug/kg/d for three days. then PBSCs were collected by means of apheresis. The collected PBSCs were infused into participant 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, 9months and 1year after treatment
Child Pugh Score	1week, 4weeks,3months, 6months, 9months and 1year after treatment
alpha fetoprotein	1week, 4weeks,3months, 6months, 9months and 1year after treatment
renal function	1week, 4weeks,3months, 6months, 9months 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 13, 2012
• First Posted (Estimate): November 20, 2012

Study Record Updates

• Last Update Posted (Estimate): November 20, 2012
• Last Update Submitted That Met QC Criteria: November 13, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: stem cell; HBV; autologous; liver cirrhosis; end stage liver disease; peripheral blood
• 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: 20120912-2