- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01221454
Allogenic Bone Marrow Stem Cell Transplantation in Liver Failure
October 15, 2010 updated by: Sun Yat-sen University
Efficacy of Allogenic Bone Marrow Stem Cells Transplantation in Patients With Liver Failure Resulting From Chronic Hepatitis B
The purpose of this study is to evaluate the therapeutic efficacy of allogenic bone marrow stem cells (BMSCs) transplantation in patients with liver failure caused by hepatitis B infection.
The evaluation of the efficacy includes the level of serum alanine aminotransferase (ALT), aspartate aminotransferase(AST), total bilirubin (TB),prothrombin time (PT), albumin (ALB), prealbumin(PA), liver histological improvement before and 1 week to 1 year after transplantation.
Child-Pugh scores, MELD scores and clinical symptoms were also observed simultaneously.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510630
- The Third Affiliated Hospital of Sun Yat-sen University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 16~65 years.
- Serum HBsAg positive for over six months.
- Meet the diagnostic criteria of liver failure:
Exclusion Criteria:
- History of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrolment.
- Prothrombin time is over 30s.
- Cirrhosis caused by other reasons except HBV infection.
- Severe problems in other vital organs(e.g.the heart,renal or lungs).
- Liver tumor on ultrasonography, CT or MRI examination.
- Pregnant or lactating women.
- Imaging evidences of vascular thromboses.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group B (BMSC Transplantion)
Thirty of the enrolled patients were assigned to Group B to receive comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine, as well as bone marrow stem cells transplantation
|
30ml allogenic bone marrow stem cells were infused to patients using interventional method via portal vein or hepatic artery as well as conserved therapy
|
Active Comparator: Group A(conserved therapy )
Thirty of the enrolled patients were assigned to Group A to receive comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.
|
Oral or intravenous administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Liver Function
Time Frame: 12 months
|
The levels of serum alanine aminotransferase (ALT), total bilirubin (TB),prothrombin time (PT), albumin (ALB), prealbumin(PA), number of leucocyte,erythrocyte and platelet, cytokines, T lymphocyte and B lymphocyte,liver histological
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Immune function
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Anticipated)
November 1, 2011
Study Completion (Anticipated)
November 1, 2011
Study Registration Dates
First Submitted
October 12, 2010
First Submitted That Met QC Criteria
October 14, 2010
First Posted (Estimate)
October 15, 2010
Study Record Updates
Last Update Posted (Estimate)
October 18, 2010
Last Update Submitted That Met QC Criteria
October 15, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYS-LF
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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