Umbilical Cord Mesenchymal Stem Cells Transplantation Combined With Plasma Exchange for Patients With Liver Failure
NCT ID: NCT01724398
Last Updated: 2013-02-28
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
120 participants
INTERVENTIONAL
2012-11-30
2015-03-31
Brief Summary
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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
Participants will receive conventional treatment and then be followed until the week 48 study visit.
Conventional treatment
Received conventional treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.
Conventional plus UC-MSC treatment
Participants will receive conventional treatment plus a dose of UC-MSC and then be followed until the week 48 study visit.
Conventional plus UC-MSC treatment
Received conventional treatment and umbilical cord mesenchymal stem cells transplantation by peripheral vein slowly for 30minutes. (1×105/Kg, once a week, 4 times).
Conventional plus PE treatment
Participants will receive conventional treatment plus plasma exchange and then be followed until the week 48 study visit.
Conventional plus PE treatment
Received conventional treatment plus 2000 milliliter plasma exchange (every 3 days, 3 times).
Conventional plus UC-MSC and PE therapy
Participants will receive conventional treatment plus umbilical cord mesenchymal stem cells transplantation combined with plasma exchange. Participants will then be followed until the week 48 study visit.
Conventional plus UC-MSC and PE therapy
Received conventional treatment plus 2000 milliliter plasma exchange (every 3 days, 3 times). Meantime taken i.v umbilical cord mesenchymal stem cells transplantation slowly for 30minutes (1×105/Kg, once a week, 4 times), the first two times is taken after plasma exchange.
Interventions
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Conventional plus UC-MSC treatment
Received conventional treatment and umbilical cord mesenchymal stem cells transplantation by peripheral vein slowly for 30minutes. (1×105/Kg, once a week, 4 times).
Conventional plus PE treatment
Received conventional treatment plus 2000 milliliter plasma exchange (every 3 days, 3 times).
Conventional plus UC-MSC and PE therapy
Received conventional treatment plus 2000 milliliter plasma exchange (every 3 days, 3 times). Meantime taken i.v umbilical cord mesenchymal stem cells transplantation slowly for 30minutes (1×105/Kg, once a week, 4 times), the first two times is taken after plasma exchange.
Conventional treatment
Received conventional treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.
Eligibility Criteria
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Inclusion Criteria
* Acute-on-Chronic liver failure caused by hepatitis B virus
* Model for End-Stage Liver Disease (MELD) \<30
Exclusion Criteria
* History of severe hepatic encephalopathy or variceal bleeding during the last two months before enrollment
* Severe problems in other vital organs(e.g. the heart, renal or lungs)
* Severe bacteria infection
* Tumor on ultrasonography, CT or MRI examination
* Pregnant or lactating women
16 Years
65 Years
ALL
No
Sponsors
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Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Responsible Party
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Zhiliang Gao
Professor
Principal Investigators
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Zhi-Liang Gao, Doctor
Role: PRINCIPAL_INVESTIGATOR
The Third Affliated Hospital of Sun Yat-sen University
Locations
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Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Zhi-Liang Gao, Professor
Role: primary
Hong-Liang He, Master
Role: backup
References
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Xu WX, He HL, Pan SW, Chen YL, Zhang ML, Zhu S, Gao ZL, Peng L, Li JG. Combination Treatments of Plasma Exchange and Umbilical Cord-Derived Mesenchymal Stem Cell Transplantation for Patients with Hepatitis B Virus-Related Acute-on-Chronic Liver Failure: A Clinical Trial in China. Stem Cells Int. 2019 Feb 4;2019:4130757. doi: 10.1155/2019/4130757. eCollection 2019.
Other Identifiers
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UCMSC-PE
Identifier Type: -
Identifier Source: org_study_id