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Autologous Mesenchymal Stem Cell Transplantation in Cirrhosis Patients With Refractory Ascites

Primary Purpose

Immune Function in Blood, Liver Function in Blood, Variation of Ascites

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

autologous bone marrow mesenchymal stem cells transplantation

autologous bone marrow msenchymal stem cells transplantation

About this trial

This is an interventional treatment trial for Immune Function in Blood focused on measuring immun function, liver function, ascites, quality of life, Child-Pugh score

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Sites / Locations

Jinling Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

autologous bone marrow mesenchymal stem cells transplantation

mesenchymal stem cells transplantation

stem cells transplantation

Arm Description

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

autologous bone marrow mesenchymal stem cells transplantation

Outcomes

Primary Outcome Measures

change in immune function,liver function in blood

Secondary Outcome Measures

Full Information

NCT ID

NCT01854125

First Posted

May 12, 2013

Last Updated

May 14, 2013

Sponsor

Nanjing PLA General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01854125

Brief Title

Autologous Mesenchymal Stem Cell Transplantation in Cirrhosis Patients With Refractory Ascites

Official Title

Efficacy of Autologous Mesenchymal Stem Cell Transplantation Via Liver Artery in Liver Cirrhosis Patients With Refractory Ascites

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Unknown status

Study Start Date

May 2013 (undefined)

Primary Completion Date

January 2014 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nanjing PLA General Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

immun function, liver function, ascites, quality of life, Child-Pugh score

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

autologous bone marrow mesenchymal stem cells transplantation

Arm Type

Active Comparator

Arm Description

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

Arm Title

mesenchymal stem cells transplantation

Arm Type

Active Comparator

Arm Description

autologous bone marrow mesenchymal stem cells transplantation

Arm Title

stem cells transplantation

Arm Type

Experimental

Arm Description

autologous bone marrow mesenchymal stem cells transplantation

Intervention Type

Biological

Intervention Name(s)

autologous bone marrow mesenchymal stem cells transplantation

Intervention Description

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

Intervention Name(s)

autologous bone marrow msenchymal stem cells transplantation

Primary Outcome Measure Information:

Title

change in immune function,liver function in blood

Time Frame

before and one to 12 weeks after therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fangyu Wang, MD/PhD

Organizational Affiliation

Nanjing University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Fangyu Wang, MD/PhD

Organizational Affiliation

Nanjin University

Official's Role

Study Director

Facility Information:

Facility Name

Jinling Hospital

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210002

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

19455046

Citation

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.

Results Reference

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Autologous Mesenchymal Stem Cell Transplantation in Cirrhosis Patients With Refractory Ascites

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