Autologous Mesenchymal Stem Cell Transplantation in Cirrhosis Patients With Refractory Ascites

NCT ID: NCT01854125

Last Updated: 2013-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Immune Function in Blood Liver Function in Blood Variation of Ascites Characters of Quality of Life Child-Pugh Score

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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autologous bone marrow mesenchymal stem cells transplantation

Every patient is given 1x106 MSCs per kg infused via liver artery

Group Type ACTIVE_COMPARATOR

autologous bone marrow mesenchymal stem cells transplantation

Intervention Type BIOLOGICAL

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.

autologous bone marrow msenchymal stem cells transplantation

Intervention Type BIOLOGICAL

mesenchymal stem cells transplantation

autologous bone marrow mesenchymal stem cells transplantation

Group Type ACTIVE_COMPARATOR

autologous bone marrow mesenchymal stem cells transplantation

Intervention Type BIOLOGICAL

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.

autologous bone marrow msenchymal stem cells transplantation

Intervention Type BIOLOGICAL

stem cells transplantation

autologous bone marrow mesenchymal stem cells transplantation

Group Type EXPERIMENTAL

autologous bone marrow mesenchymal stem cells transplantation

Intervention Type BIOLOGICAL

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.

autologous bone marrow msenchymal stem cells transplantation

Intervention Type BIOLOGICAL

Interventions

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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.

Intervention Type BIOLOGICAL

autologous bone marrow msenchymal stem cells transplantation

Intervention Type BIOLOGICAL

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shihui

Department of Gastroenterology and Hepatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fangyu Wang, MD/PhD

Role: STUDY_DIRECTOR

Nanjing University

Fangyu Wang, MD/PhD

Role: STUDY_DIRECTOR

Nanjin University

Locations

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Jinling Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

References

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Kharaziha P, Hellstrom PM, Noorinayer B, Farzaneh F, Aghajani K, Jafari F, Telkabadi M, Atashi A, Honardoost M, Zali MR, Soleimani M. Improvement of liver function in liver cirrhosis patients after autologous mesenchymal stem cell injection: a phase I-II clinical trial. Eur J Gastroenterol Hepatol. 2009 Oct;21(10):1199-205. doi: 10.1097/MEG.0b013e32832a1f6c.

Reference Type BACKGROUND
PMID: 19455046 (View on PubMed)

Other Identifiers

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Jinling 01

Identifier Type: OTHER

Identifier Source: secondary_id

NanjingPLAGH1

Identifier Type: -

Identifier Source: org_study_id

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