Autologous Mesenchymal Stem Cell Transplantation in Cirrhosis Patients With Refractory Ascites
May 14, 2013 updated by: Shihui, Nanjing PLA General Hospital
Efficacy of Autologous Mesenchymal Stem Cell Transplantation Via Liver Artery in Liver Cirrhosis Patients With Refractory Ascites
Liver cirrhosis (LC) is the final destiny in chronic liver disease.The quality of life in liver cirrhosis patients with refractory ascites are very wretched.
The objective of this study is to evaluate the therapeutic efficacy of autologous bone marrow mesenchymal stem cells (BMSCs) transplantation via liver artery in Child-Pugh B and C stage of liver cirrhosis patients with refractory ascites.
The immunomodulatory impact of MSCs in fibrosis was confirmed, and several clinical studies have applied MSCs to eliminate the progression of fibrosis.
In this research the investigators will study the affect and influence of MSCs in the patients,include assay of liver function,variation of ascites,Child-Pugh score etc.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Jiangsu
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Nanjing, Jiangsu, China, 210002
- Jinling Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:Inclusion Criteria:
Aged 18~65 years. Ultrasonographic evidences of cirrhosis. hepatic cirrhosis patients with refractory ascite.
Exclusion Criteria:
history of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrolment.
Prothrombin time is less than 30s. Severe problems in other vital organs(e.g.the heart,renal or lungs). Liver tumor on ultrasonography, CT or MRI examination. Pregnant or lactating women. Imaging evidences of vascular thromboses.
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Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: autologous bone marrow mesenchymal stem cells transplantation
Every patient is given 1x106 MSCs per kg infused via liver artery
|
Autologous MSCs were infused to patients using interventional method via hepatic artery .
The catheter was inserted to proper hepatic artery.
After the catheter placed at proper hepatic artery was confirmed by angiography, autologous bone marrow MSCs were infused slowly for 20-30 minutes.
|
|
Active Comparator: mesenchymal stem cells transplantation
autologous bone marrow mesenchymal stem cells transplantation
|
Autologous MSCs were infused to patients using interventional method via hepatic artery .
The catheter was inserted to proper hepatic artery.
After the catheter placed at proper hepatic artery was confirmed by angiography, autologous bone marrow MSCs were infused slowly for 20-30 minutes.
|
|
Experimental: stem cells transplantation
autologous bone marrow mesenchymal stem cells transplantation
|
Autologous MSCs were infused to patients using interventional method via hepatic artery .
The catheter was inserted to proper hepatic artery.
After the catheter placed at proper hepatic artery was confirmed by angiography, autologous bone marrow MSCs were infused slowly for 20-30 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
change in immune function,liver function in blood
Time Frame: before and one to 12 weeks after therapy
|
before and one to 12 weeks after therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Fangyu Wang, MD/PhD, Nanjing university
- Study Director: Fangyu Wang, MD/PhD, Nanjin University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Anticipated)
January 1, 2014
Study Registration Dates
First Submitted
May 12, 2013
First Submitted That Met QC Criteria
May 14, 2013
First Posted (Estimate)
May 15, 2013
Study Record Updates
Last Update Posted (Estimate)
May 15, 2013
Last Update Submitted That Met QC Criteria
May 14, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NanjingPLAGH1
- Jinling 01 (Other Identifier: Jinling Hospital)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.