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

NCT00976287 | Unknown Phase 2 DMC

• 1 other identifier: zssy
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Liver Cirrhosis

Keywords

Stem cells; Liver cirrhosis; Radiology; Interventional; Transplantation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Conserved Therapy

ACTIVE COMPARATOR

Conserved Therapy

Procedure: Conserved Therapy

Interventional Therapy

EXPERIMENTAL

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

Interventions

Hepatic artery infusion PROCEDURE

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.

Also known as: interventional therapy

Interventional Therapy

Conserved Therapy PROCEDURE

Conserved Therapy

Also known as: interventional, hepatic infusion

Conserved Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Methods

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Zhu k shun, PHD

  SunYat-sen University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 31, 2009
• First Posted: September 14, 2009
• Study Start: January 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: June 1, 2010
• Last Updated: September 15, 2009

Record last verified: 2009-09