Safety and Efficacy of Human Bone Marrow Stem Cells for Treatment of HBV-related Liver Cirrhosis
NCT ID: NCT01724697
Last Updated: 2012-11-12
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.
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.
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 treatment
conventional treatment \& antivrial treatment.
conventional treatment & antivrial treatment
Participants will recieve conventional treatment and antivrial treatment.
BMSC transplantation
conventional treatment \& antiviral treatment \& autologous bone marrow stem cell transplantation via hepatic artery
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.
Interventions
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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.
conventional treatment & antivrial treatment
Participants will recieve conventional treatment and antivrial 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.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
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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Facility Contacts
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Ying Han
Role: primary
Yongquan Shi
Role: backup
Other Identifiers
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20120912-1
Identifier Type: -
Identifier Source: org_study_id