Allogenic Bone Marrow Stem Cell Transplantation in Liver Failure

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2010 by Sun Yat-sen University.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT01221454

First received: October 12, 2010

Last updated: October 15, 2010

Last verified: October 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	October 12, 2010
Last Updated Date	October 15, 2010
Start Date ^ICMJE	October 2010
Estimated Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 15, 2010)	Liver Function [ Time Frame: 12 months ] [ Designated as safety issue: No ] 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
Original Primary Outcome Measures ^ICMJE (submitted: October 14, 2010)	Liver Function [ Time Frame: Every one month ] [ Designated as safety issue: No ] 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
Change History	Complete list of historical versions of study NCT01221454 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 15, 2010)	Immune function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: October 14, 2010)	Immune function [ Time Frame: Every one month ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Allogenic Bone Marrow Stem Cell Transplantation in Liver Failure
Official Title ^ICMJE	Efficacy of Allogenic Bone Marrow Stem Cells Transplantation in Patients With Liver Failure Resulting From Chronic Hepatitis B
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Liver Failure
Intervention ^ICMJE	Procedure: Allogenic 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 Drug: Conserved therapy Oral or intravenous administration
Study Arm (s)	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. Intervention: Drug: Conserved therapy 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 Intervention: Procedure: Allogenic bone marrow stem cells transplantation
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	60
Estimated Completion Date	November 2011
Estimated Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	16 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	China

Administrative Information
NCT Number ^ICMJE	NCT01221454
Other Study ID Numbers ^ICMJE	SYS-LF
Has Data Monitoring Committee	Yes
Responsible Party	Lin Bingliang, Third Affiliated Hospital, Sun Yat-sen University
Study Sponsor ^ICMJE	Sun Yat-sen University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Sun Yat-sen University
Verification Date	October 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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