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Autologous Mesenchymal Stem Cell Transplantation in Cirrhosis Patients With Refractory Ascites

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ClinicalTrials.gov Identifier: NCT01854125
Recruitment Status : Unknown
Verified May 2013 by Shihui, Nanjing PLA General Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : May 15, 2013
Last Update Posted : May 15, 2013
Sponsor:
Information provided by (Responsible Party):
Shihui, Nanjing PLA General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Immune Function in Blood Liver Function in Blood Variation of Ascites Characters of Quality of Life Child-Pugh Score Biological: autologous bone marrow mesenchymal stem cells transplantation Biological: autologous bone marrow msenchymal stem cells transplantation Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Autologous Mesenchymal Stem Cell Transplantation Via Liver Artery in Liver Cirrhosis Patients With Refractory Ascites
Study Start Date : May 2013
Estimated Primary Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arm Intervention/treatment
Active Comparator: autologous bone marrow mesenchymal stem cells transplantation
Every patient is given 1x106 MSCs per kg infused via liver artery
Biological: 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.

Biological: autologous bone marrow msenchymal stem cells transplantation
Active Comparator: mesenchymal stem cells transplantation
autologous bone marrow mesenchymal stem cells transplantation
Biological: 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.

Biological: autologous bone marrow msenchymal stem cells transplantation
Experimental: stem cells transplantation
autologous bone marrow mesenchymal stem cells transplantation
Biological: 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.

Biological: autologous bone marrow msenchymal stem cells transplantation



Primary Outcome Measures :
  1. change in immune function,liver function in blood [ Time Frame: before and one to 12 weeks after therapy ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01854125


Locations
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China, Jiangsu
Jinling Hospital
Nanjing, Jiangsu, China, 210002
Sponsors and Collaborators
Nanjing PLA General Hospital
Investigators
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Study Director: Fangyu Wang, MD/PhD Nanjing University
Study Director: Fangyu Wang, MD/PhD Nanjin University

Publications:
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Responsible Party: Shihui, Department of Gastroenterology and Hepatology, Nanjing PLA General Hospital
ClinicalTrials.gov Identifier: NCT01854125     History of Changes
Other Study ID Numbers: NanjingPLAGH1
Jinling 01 ( Other Identifier: Jinling Hospital )
First Posted: May 15, 2013    Key Record Dates
Last Update Posted: May 15, 2013
Last Verified: May 2013

Keywords provided by Shihui, Nanjing PLA General Hospital:
immun function
liver function
ascites
quality of life
Child-Pugh score

Additional relevant MeSH terms:
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Ascites
Pathologic Processes