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Clinical Trials/NCT01224327
NCT01224327
Unknown
Phase 1

The Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion Via Hepatic Artery in Cirrhosis Patients.

Qingdao University1 site in 1 country50 target enrollmentOctober 2010

Overview

Phase
Phase 1
Intervention
umbilical cord Mesenchymal Stem Cells
Conditions
Liver Cirrhosis
Sponsor
Qingdao University
Enrollment
50
Locations
1
Primary Endpoint
The result of liver function and liver histological improvement.
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
December 2012
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Qingdao University

Eligibility Criteria

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
  • 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

Arms & Interventions

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.

Intervention: umbilical cord Mesenchymal Stem Cells

Conserved therapy

Patients received comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.

Intervention: Conserved therapy

Outcomes

Primary Outcomes

The result of liver function and liver histological improvement.

Time Frame: every 4 weeks

Secondary Outcomes

  • 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)

Study Sites (1)

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