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Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis

Primary Purpose

Liver Cirrhosis, End Stage Liver Disease

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
PBSC transplantation
conventional treatment
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring liver cirrhosis, stem cell, peripheral blood, autologous, HBV, end stage liver disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

  • Xijing Hospital of Digestive DiseaseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional

conventional & PBSC transplantation

Arm Description

conventional treatment & antiviral treatment

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.

Outcomes

Primary Outcome Measures

one-year survival rate

Secondary Outcome Measures

MELD score
Child Pugh Score
alpha fetoprotein
renal function

Full Information

First Posted
October 31, 2012
Last Updated
November 13, 2012
Sponsor
Air Force Military Medical University, China
Collaborators
The Second Affiliated Hospital of Chongqing Medical University, Eastern Hepatobiliary Surgery Hospital, Chinese Academy of Medical Sciences, Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT01728688
Brief Title
Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis
Official Title
Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China
Collaborators
The Second Affiliated Hospital of Chongqing Medical University, Eastern Hepatobiliary Surgery Hospital, Chinese Academy of Medical Sciences, Fudan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, End Stage Liver Disease
Keywords
liver cirrhosis, stem cell, peripheral blood, autologous, HBV, end stage liver disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
conventional treatment & antiviral treatment
Arm Title
conventional & PBSC transplantation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
PBSC transplantation
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
conventional treatment
Intervention Description
Participants will receive conventional treatment and antiviral treatment.
Primary Outcome Measure Information:
Title
one-year survival rate
Time Frame
one year after treatment
Secondary Outcome Measure Information:
Title
MELD score
Time Frame
1week, 4weeks,3months, 6months, 9months and 1year after treatment
Title
Child Pugh Score
Time Frame
1week, 4weeks,3months, 6months, 9months and 1year after treatment
Title
alpha fetoprotein
Time Frame
1week, 4weeks,3months, 6months, 9months and 1year after treatment
Title
renal function
Time Frame
1week, 4weeks,3months, 6months, 9months and 1year after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18-65 years HBV-related liver cirrhosis Child-Pugh score 9-15 Written consent Exclusion Criteria: Hepatocellular carcinoma or other malignancies Severe problems in other vital organs(e.g.the heart,renal or lungs) Pregnant or lactating women Severe bacteria infection Anticipated with difficulty of follow-up observation Other candidates who are judged to be not applicable to this study by doctors -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Han
Phone
86-29-84771539
Email
hanying@fmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yongquan Shi
Phone
86-29-84771515
Email
shiyquan@fmmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daiming Fan
Organizational Affiliation
Air Force Military Medical University, China
Official's Role
Study Chair
Facility Information:
Facility Name
Xijing Hospital of Digestive Disease
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Han
Phone
86-29-84771539
Email
hanying@fmmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yongquan Shi
Phone
86-29-84771515
Email
shiyquan@fmmu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis

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