- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01854125
Autologous Mesenchymal Stem Cell Transplantation in Cirrhosis Patients With Refractory Ascites
Efficacy of Autologous Mesenchymal Stem Cell Transplantation Via Liver Artery in Liver Cirrhosis Patients With Refractory Ascites
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210002
- Jinling Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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.
-
Exclusion Criteria:
-
Study Plan
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
Sponsor
Investigators
- Study Director: Fangyu Wang, MD/PhD, Nanjing University
- Study Director: Fangyu Wang, MD/PhD, Nanjin University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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.
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