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

Qingdao University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Radiology; Liver Cirrhosis; Mesenchymal Stem Cells; Umbilical Cord

Treatments: Drug: Conserved therapy; Biological: umbilical cord Mesenchymal Stem Cells

Study type: Interventional

Funder types: Other

Identifiers

NCT01224327

MSCHC005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

umbilical cord mesenchymal stem cells

Experimental group

Description:

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.

Treatment:

Biological: umbilical cord Mesenchymal Stem Cells

Conserved therapy

Active Comparator group

Description:

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

Treatment:

Drug: Conserved therapy