Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis
NCT ID: NCT01728688
Last Updated: 2012-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
240 participants
INTERVENTIONAL
2012-09-30
2015-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional
conventional treatment \& antiviral treatment
conventional treatment
Participants will receive conventional treatment and antiviral treatment.
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.
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
Interventions
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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
conventional treatment
Participants will receive conventional treatment and antiviral treatment.
Eligibility Criteria
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Inclusion Criteria
2. HBV-related liver cirrhosis
3. Child-Pugh score 9-15
4. Written consent
Exclusion Criteria
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 -
18 Years
65 Years
ALL
No
Sponsors
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The Second Affiliated Hospital of Chongqing Medical University
OTHER
Eastern Hepatobiliary Surgery Hospital
OTHER
Chinese Academy of Medical Sciences
OTHER
Fudan University
OTHER
Air Force Military Medical University, China
OTHER
Responsible Party
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Han Ying
professor
Principal Investigators
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Daiming Fan
Role: STUDY_CHAIR
Air Force Military Medical University, China
Locations
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Xijing Hospital of Digestive Disease
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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Ying Han
Role: primary
Yongquan Shi
Role: backup
Other Identifiers
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20120912-2
Identifier Type: -
Identifier Source: org_study_id