Autologous Bone Marrow Mesenchymal Stem Cells Transplantation Via Hepatic Artery in Patients With Liver Cirrhosis

Liver Cirrhosis Clinical Trial

Official title:

Autologous Bone Marrow Mesenchymal Stem Cells Transplantation Via Hepatic Artery in Patients With Liver Cirrhosis

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00976287
• Other study ID #: zssy
• Status: Unknown status
• Phase: Phase 2
• First received: August 31, 2009
• Last updated: September 14, 2009
• Start date: January 2008
• Est. completion date: June 2010

Study information

• Verified date: September 2009
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 50
• Est. completion date: June 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis

Intervention

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.
• Conserved Therapy
Conserved Therapy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Third Affiliated Hospital, Sun Yat-Sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The levels of serum alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT), albumin (ALB)		pre-transplantation, and 3 days to 2 years post-transplantation

External Links

•   Link