Safety and Efficacy of Diverse Mesenchymal Stem Cells Transplantation for Liver Failure
NCT ID: NCT01844063
Last Updated: 2013-07-08
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1/PHASE2
210 participants
INTERVENTIONAL
2013-07-31
2019-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Allogene MSCs Transplantation in Patients With Chronic Liver Diseases Through Peripheral Vein.
NCT01256125
Allogene MSCs Transplantation in Liver for Patients With Chronic Liver Diseases Through Portal Vein by Ultrasound Guiding
NCT01256138
Adjuvant Lenvatinib Prevents Recurrence of High-risk Patients With HBV-related HCC After Liver Transplantation
NCT04415567
Liver Transplantation Results in Hepatocellular Carcinoma Patients With Immunosuppression Without Steroids
NCT01137084
A Study of TCR-Redirected T Cell Infusion to Prevent Hepatocellular Carcinoma Recurrence Post Liver Transplantation
NCT02686372
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Conventional treatment
Participants will receive conventional treatment and then be followed until the week 72 study visit.
Conventional treatment
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.
Conventional plus BM-MSC treatment
Participants 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 BM-MSC treatment
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).
Conventional plus UC-MSC treatment
Participants 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.
Conventional plus UC-MSC treatment
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)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Conventional plus BM-MSC treatment
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).
Conventional plus UC-MSC treatment
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)
Conventional treatment
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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%
* 17≤MELD score≤30
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Qi Zhang, MD
Deputy Director, Office of International Cooperation & Exchange Office of Hongkong, Macao & Taiwan Affairs
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Qi Zhang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Third Affiliated Hospital, Sun Yat-Sen University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Qi Zhang
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
The Third Affiliated Hospital
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.