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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01224327
Other study ID # MSCHC005
Secondary ID
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


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
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