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.
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2010
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 18, 2010
CompletedFirst Posted
Study publicly available on registry
October 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedOctober 20, 2010
September 1, 2010
2 years
October 18, 2010
October 19, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The result of liver function and liver histological improvement.
every 4 weeks
Secondary Outcomes (2)
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 Arms (2)
umbilical cord mesenchymal stem cells
EXPERIMENTALUmbilical 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.
Conserved therapy
ACTIVE COMPARATORPatients received comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Aged 18\~70 years.
- Liver cirrhosis
- written consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stem Cell Research Center of Medical School Hospital of Qingdao University
Qingdao, Shandong, 266003, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zibin Tian, MD
The Affiliated Hospital of Qingdao University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 18, 2010
First Posted
October 20, 2010
Study Start
October 1, 2010
Primary Completion
October 1, 2012
Study Completion
December 1, 2012
Last Updated
October 20, 2010
Record last verified: 2010-09