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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Qingdao University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Qingdao University
ClinicalTrials.gov Identifier:
NCT01224327
First received: October 18, 2010
Last updated: October 19, 2010
Last verified: September 2010

October 18, 2010
October 19, 2010
October 2010
October 2012   (final data collection date for primary outcome measure)
The result of liver function and liver histological improvement. [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01224327 on ClinicalTrials.gov Archive Site
  • The disappearance or reduction of abdominal dropsy [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]
  • The clinical symptom improve(including food appetite,debilitation,abdominal distension,edema of lower limbs ) [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Umbilical Cord Mesenchymal Stem Cells Infusion Via Hepatic Artery in Cirrhosis Patients
The Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion Via Hepatic Artery in Cirrhosis Patients.

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Liver Cirrhosis
  • Radiology
  • Mesenchymal Stem Cells
  • Umbilical Cord
  • 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.
    Other Name: Mesenchymal Stem Cells
  • Drug: Conserved therapy
    Oral or intravenous administration
    Other Name: Drug therapy
  • Experimental: 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: Biological: umbilical cord Mesenchymal Stem Cells
  • Active Comparator: Conserved therapy
    Patients received comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.
    Intervention: Drug: Conserved therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
December 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Jianxia Hu, MD 86-0532-82911676 qdyxyhjx@126.com
Contact: Hong Gao, MS 86-0532-82911676 honggaogloria@gmail.com
China
 
NCT01224327
MSCHC005
Yes
Wang, Yangang MD, Stem Cell Research Center of Medical School Hospital of Qingdao University
Qingdao University
Not Provided
Study Director: Zibin Tian, MD The Affiliated Hospital of Medical College of Qingdao University
Qingdao University
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP