Autologous Bone Marrow Mesenchymal Stem Cells Transplantation Via Hepatic Artery in Patients With Liver Cirrhosis - Full Text View

Sponsor:	Sun Yat-sen University
Collaborator:	Third Affiliated Hospital, Sun Yat-Sen University
Information provided by:	Sun Yat-sen University
ClinicalTrials.gov Identifier:	NCT00976287

Purpose

The purpose of this study is to investigate the efficacy of autologous bone marrow mesenchymal stem cells (MSCs) transplantation via hepatic artery in the treatment of liver cirrhosis. Liver function was monitored by serum examination. The levels of serum alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT) and albumin (ALB) were examined at pre-transplantation, and 3 days to 2 years post-transplantation. Child-Pugh scores and clinical symptoms were also observed simultaneously.

Condition	Intervention	Phase
Liver Cirrhosis	Procedure: Hepatic artery infusion Procedure: Conserved Therapy	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Autologous Bone Marrow Mesenchymal Stem Cells Transplantation Via Hepatic Artery in Patients With Liver Cirrhosis

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis

U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:

The levels of serum alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT), albumin (ALB) [ Time Frame: pre-transplantation, and 3 days to 2 years post-transplantation ] [ Designated as safety issue: Yes ]

Enrollment:	50
Study Start Date:	January 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Conserved Therapy Conserved Therapy	Procedure: Conserved Therapy Conserved Therapy Other Names: interventional hepatic infusion
Experimental: Interventional Therapy Patients with liver cirrhosis were randomly separated into two groups. Autologous MSCs were infused to patients using interventional method via hepatic artery for One group. The catheter was inserted to proper hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography, autologous bone marrow MSCs were infused slowly for 20-30 minutes. The control group accepted conserved therapy.	Procedure: Hepatic artery infusion Patients with liver cirrhosis were randomly separated into two groups. Autologous MSCs were infused to patients using interventional method via hepatic artery for One group. The catheter was inserted to proper hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography, autologous bone marrow MSCs were infused slowly for 20-30 minutes. The control group accepted conserved therapy. Other Name: interventional therapy

Arms

Assigned Interventions

Active Comparator: Conserved Therapy

Conserved Therapy

Procedure: Conserved Therapy

Conserved Therapy

Other Names:

interventional
hepatic infusion

Experimental: Interventional Therapy

Patients with liver cirrhosis were randomly separated into two groups. Autologous MSCs were infused to patients using interventional method via hepatic artery for One group. The catheter was inserted to proper hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography, autologous bone marrow MSCs were infused slowly for 20-30 minutes. The control group accepted conserved therapy.

Procedure: Hepatic artery infusion

Patients with liver cirrhosis were randomly separated into two groups. Autologous MSCs were infused to patients using interventional method via hepatic artery for One group. The catheter was inserted to proper hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography, autologous bone marrow MSCs were infused slowly for 20-30 minutes. The control group accepted conserved therapy.

Other Name: interventional therapy

Detailed Description:

Patients with liver cirrhosis were randomly separated into two groups. Autologous MSCs were infused to patients using interventional method via hepatic artery for One group. The catheter was inserted to proper hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography, autologous bone marrow MSCs were infused slowly for 20-30 minutes. The control group accepted conserved therapy.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18-70 years.
Imaging evidences of liver cirrhosis.
Child-Plough score of 10 or more.

Exclusion Criteria:

Liver tumor on ultrasonography, CT or MRI examination.
Problems in organs other than the liver(e.g.the heart or lungs).
History of moderate to severe hepatic encephalopathy or variceal bleeding.
Imaging evidences of vascular thromboses.
Coma.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00976287

Sponsors and Collaborators

Sun Yat-sen University

Third Affiliated Hospital, Sun Yat-Sen University

Investigators

Study Director:

Zhu k shun, PHD

SunYat-sen University

More Information

No publications provided

Responsible Party:	Sun Yat-sen university
ClinicalTrials.gov Identifier:	NCT00976287 History of Changes
Other Study ID Numbers:	zssy
Study First Received:	August 31, 2009
Last Updated:	September 14, 2009
Health Authority:	China: Ministry of Health

Keywords provided by Sun Yat-sen University:

Stem cells
Liver cirrhosis
Radiology
Interventional
Transplantation

Additional relevant MeSH terms:

Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012