Safety and Efficacy of Diverse Mesenchymal Stem Cells Transplantation for Liver Failure
Clinical Comparison of Safety and Efficacy of Allogeneic Umbilical-Cord and Bone Marrow-derived Mesenchymal Stem Cells Transplantation for HBV-related Liver Failure
1 other identifier
interventional
210
1 country
1
Brief Summary
HBV-related liver failure (HBV-LF), a dramatic clinical syndrome, is characterized with massive necrosis of liver cells. Liver transplantation might be the most effective therapy for HBV-LF. However, there are a lot of problems such as lack of donors, surgical complications, transplant rejection, and high cost, which could limit the application of liver transplantation. It is demonstrated that mesenchymal stem cells could directionally differentiate into hepatocytes and cholangiocytes in injured liver, as well as reduce inflammation of the liver by immune regulation. In this study, we assess the safety and efficacy of human bone marrow and umbilical cord mesenchymal stem cells transplantation for patients with HBV-LF.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2013
Longer than P75 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
First Submitted
Initial submission to the registry
April 20, 2013
CompletedFirst Posted
Study publicly available on registry
May 1, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedJuly 8, 2013
July 1, 2013
2.5 years
April 20, 2013
July 4, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
survival rate
The survival rate and time
72 weeks
Secondary Outcomes (8)
Liver function
72 weeks after treatment
Marker of liver cancer
72 weeks after treatment
The degree of hepatic necrosis
2 years after treatment
The improvement of symptoms
72 weeks after treatment
The score for Model for End-Stage Liver Disease
72 weeks after treatment
- +3 more secondary outcomes
Study Arms (3)
Conventional treatment
EXPERIMENTALParticipants will receive conventional treatment and then be followed until the week 72 study visit.
Conventional plus BM-MSC treatment
EXPERIMENTALParticipants will receive conventional treatment plus a dose of BM-MSC(each subgroups with a different dose ) and then be followed until the week 72 study visit.
Conventional plus UC-MSC treatment
EXPERIMENTALParticipants will receive conventional treatment plus a dose of UC-MSC(each subgroups with a different dose ) and then be followed until the week 72 study visit.
Interventions
Received conventional treatment and bone marrow mesenchymal stem cells transplantation by peripheral vein slowly for 30minutes. (1×10e5/Kg,1×10e6/Kg,or 1×10e7/Kg, once a week, 8 times).
Received conventional treatment and bone marrow mesenchymal stem cells transplantation by peripheral vein slowly for 30minutes. (1×10e5/Kg,1×10e6/Kg,or 1×10e7/Kg, once a week, 8 times)
Received conventional treatment including: A.antiviral drugs(Entecavir,Lamivudine,Adefovir dipivoxil,et al); B.Hepatoprotective drugs(Ademetionine1,4-butanethiosulfonate for Injection, Reduced Glutathione for Injection,Polyene Phosphatidylcholine, et al); C.Plasma.
Eligibility Criteria
You may qualify if:
- Aged 18-65 years
- Liver failure
- Negative pregnancy test (female patients in fertile age)
- Written consent
- HBsAg positive
- TB≥171 μmol/L or ascend ≥17.1 μmol/L/per day,
- INR≥1.5 or 20%\<PTA≤40%
- ≤MELD score≤30
You may not qualify if:
- Hepatocellular carcinoma or other malignancies
- Severe problems in other vital organs(e.g.the heart,renal or lungs)
- Pregnant or lactating women
- Severe bacteria infection
- Anticipated with difficulty of follow-up observation
- Liver failure caused by other reasons, such as autoimmune diseases, alcohol, drug and so on
- Other candidates who are judged to be not applicable to this study by doctors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Qi Zhang
Guangzhou, Guangdong, 510630, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qi Zhang, Doctor
Third Affiliated Hospital, 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
- Deputy Director, Office of International Cooperation & Exchange Office of Hongkong, Macao & Taiwan Affairs
Study Record Dates
First Submitted
April 20, 2013
First Posted
May 1, 2013
Study Start
July 1, 2013
Primary Completion
January 1, 2016
Study Completion
January 1, 2019
Last Updated
July 8, 2013
Record last verified: 2013-07