Safety and Efficacy of Human Umbilical Cord Derived Mesenchymal Stem Cells for Treatment of HBV-related Liver Cirrhosis
NCT ID: NCT01728727
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.
Mesenchymal stem cells (MSCs) possess plasticity and have the potential to differentiate into hepatocyte; Thus, MSCs hold great hope for therapeutic applications. Human umbilical cord-derived MSCs (hUC-MSCs) exhibit a more beneficial immunogenic profile and greater overall immunosuppressive potential than aged bone marrow-derived MSCs. Like MSCs derived from bone marrow, hUC-MSCs can also be used to treat rat liver fibrosis and improve glucose homeostasis in rats with liver cirrhosis. In this study, the patients with HBV-related liver cirrhosis will undergo administration of hUC-MSCs via hepatic artery to evaluate the safety and efficacy of hUC-MSC 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.
UC-MSC transplantation
Participants will receive umbilical cord derived mesenchymal stem cell treatment at day 1 and conventional treatment and antiviral treatment through the one year study visit. Participants will then be followed until one years study visit
UC-MSC transplantation
After enrolled, Participant will receive umbilical cord MSC transplantation of 1\*10E6 cells/kg via hepatic artery. Participant will then be followed until 1 years study visit
Interventions
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UC-MSC transplantation
After enrolled, Participant will receive umbilical cord MSC transplantation of 1\*10E6 cells/kg via hepatic artery. Participant will then be followed until 1 years study visit
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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20120912-3
Identifier Type: -
Identifier Source: org_study_id