Umbilical Cord Mesenchymal Stem Cells Infusion Via Hepatic Artery in Cirrhosis Patients

Phase 1

• Conditions: Liver Cirrhosis; Radiology; Mesenchymal Stem Cells; Umbilical Cord
• Interventions: Biological: umbilical cord Mesenchymal Stem Cells; Drug: Conserved therapy

• Registration Number: NCT01224327
• Lead Sponsor: Qingdao University

Brief Summary

The purpose of this study is to investigate the efficacy of umbilical cord mesenchymal stem cells (MSCs) infusion via hepatic artery in the treatment of liver cirrhosis.

Detailed Description

To investigate the efficacy of umbilical cord mesenchymal stem cells (MSCs) infusion via hepatic artery in the treatment of liver cirrhosis. Patients with liver cirrhosis were randomly separated into two groups. Umbilical cord MSCs were infused to patients using interventional method via hepatic artery for One group. After the catheter placed at proper hepatic artery was confirmed by angiography, umbilical cord MSCs were infused slowly for 15-20minutes. The control group accepted conserved therapy.

Study Timeline

• Status Verified: 2010-09
• Study Start: 2010-10
• Study First Submitted: 2010-10-18
• Study First Submitted QC: 2010-10-19
• Last Update Submitted: 2010-10-19
• Study First Posted: 2010-10-20
• Last Update Posted: 2010-10-20
• Primary Completion: 2012-10
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Aged 18~70 years.
• Liver cirrhosis
• written consent

Exclusion Criteria

• The end-stage of liver cirrhosis.
• Severe problems in other vital organs(e.g.the heart,renal or lungs).
• Hepatocellular carcinoma or other malignancies
• Pregnancy
• sepsis
• Presence of significant extrahepatic biliary disease (e.g. CBD stone, PSC, etc.)
• Cardiac, renal or respiratory failure
• Active thrombosis of the portal or hepatic veins

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
umbilical cord mesenchymal stem cells	umbilical cord Mesenchymal Stem Cells	Umbilical cord mesenchymal stem cells were infused to patients using interventional method via hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography,umbilical cord MSCs were infused slowly for 15-20minutes.
Conserved therapy	Conserved therapy	Patients received comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.

Primary Outcome Measures

Name	Time	Method
The result of liver function and liver histological improvement.	every 4 weeks

Secondary Outcome Measures

Name	Time	Method
The disappearance or reduction of abdominal dropsy	every 4 weeks
The clinical symptom improve(including food appetite,debilitation,abdominal distension,edema of lower limbs )	every 4 weeks

Trial Locations

Locations (1)

Stem Cell Research Center of Medical School Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China