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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01224327
• Other study ID #: MSCHC005
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: October 18, 2010
• Last updated: October 19, 2010
• Start date: October 2010
• Est. completion date: December 2012

Study information

• Verified date: September 2010
• Source: Qingdao University
• Contact: Jianxia Hu, MD
• Phone: 86-0532-82911676
• Email: qdyxyhjx[@]126.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Cirrhosis
• Mesenchymal Stem Cells
• Radiology
• Umbilical Cord

Intervention

Biological:
• 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.

Drug:
• Conserved therapy
Oral or intravenous administration

Locations

Country	Name	City	State
China	Stem Cell Research Center of Medical School Hospital of Qingdao University	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The result of liver function and liver histological improvement.		every 4 weeks	No
Secondary	The disappearance or reduction of abdominal dropsy		every 4 weeks	No
Secondary	The clinical symptom improve(including food appetite,debilitation,abdominal distension,edema of lower limbs )		every 4 weeks	No