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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Liver Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Conserved Therapy

Group Type ACTIVE_COMPARATOR

Conserved Therapy

Intervention Type PROCEDURE

Conserved Therapy

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.

Group Type EXPERIMENTAL

Hepatic artery infusion

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Conserved Therapy

Intervention Type PROCEDURE

Other Intervention Names

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interventional therapy interventional hepatic infusion

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No