Umbilical Cord Mesenchymal Stem Cells Transplantation Combined With Plasma Exchange for Patients With Liver Failure
Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells Transplantation Combined With Plasma Exchange for Patients With Acute-on-Chronic Liver Failure Caused by Hepatitis B Virus (HBV)
1 other identifier
interventional
120
1 country
1
Brief Summary
Liver failure (LF) is a dramatic clinical syndrome with massive necrosis of liver cells. Although liver transplantation provides an option to cure patients suffering with LF, lack of donors, postoperative complications, especially rejection, and high cost limit its application. Previous study showed that bone marrow derived mesenchymal stem cells (BM-MSCs) the novel and promising therapeutic strategy, BM-MSCs can replace hepatocytes in injured liver, and effectively rescue experimental liver failure and contribute to liver regeneration. Plasma exchange (PE) can improve internal environment by removing endotoxin, it helps the liver regeneration and functional recovery and make UC-MSC differentiation into hepatocyte like cells, and exert immunomodulatory function. In this study, safety and efficacy of human umbilical cord mesenchymal stem cells (UC-MSCs) transplantation combined with plasma exchange (PE) for patients with liver failure caused by hepatitis B Virus will be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2012
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 4, 2012
CompletedFirst Posted
Study publicly available on registry
November 9, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedFebruary 28, 2013
February 1, 2013
2.3 years
November 4, 2012
February 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival rate and time
48 weeks
Secondary Outcomes (6)
Improve biochemical indexes [alanine aminotransferase (ALT), albumin (ALB), total bilirubin (TBIL), prothrombin time (PT), INR and so on]
24 weeks after treatment
The clinical symptom improvement [including appetite, debilitation, abdominal distension, edema of lower limbs, et al]
24 weeks after treatment
Liver function evaluation using Child-Pugh score and MELD score
24 weeks after treatment
Immune function improvement [including Th1/Th2]
24 weeks after treatment
The occurrence of complications [including body temperature, tetter and allergy]
Between 0 to 8 hours after UC-MSCs transfusion
- +1 more secondary outcomes
Study Arms (4)
Conventional treatment
EXPERIMENTALParticipants will receive conventional treatment and then be followed until the week 48 study visit.
Conventional plus UC-MSC treatment
EXPERIMENTALParticipants will receive conventional treatment plus a dose of UC-MSC and then be followed until the week 48 study visit.
Conventional plus PE treatment
EXPERIMENTALParticipants will receive conventional treatment plus plasma exchange and then be followed until the week 48 study visit.
Conventional plus UC-MSC and PE therapy
EXPERIMENTALParticipants 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.
Interventions
Received conventional treatment and umbilical cord mesenchymal stem cells transplantation by peripheral vein slowly for 30minutes. (1×105/Kg, once a week, 4 times).
Received conventional treatment plus 2000 milliliter plasma exchange (every 3 days, 3 times).
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.
Received conventional treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.
Eligibility Criteria
You may qualify if:
- Written informed consent
- Acute-on-Chronic liver failure caused by hepatitis B virus
- Model for End-Stage Liver Disease (MELD) \<30
You may not qualify if:
- Liver failure caused by other reasons, such as autoimmune diseases, alcohol, drug and so on
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630, China
Related Publications (1)
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.
PMID: 30863450DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhi-Liang Gao, Doctor
The Third Affliated Hospital of Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 4, 2012
First Posted
November 9, 2012
Study Start
November 1, 2012
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
February 28, 2013
Record last verified: 2013-02