ClinicalTrials.Veeva

Menu

Autologous Mesenchymal Stem Cell Transplantation in Cirrhosis Patients With Refractory Ascites

N

Nanjing PLA General Hospital

Status and phase

Unknown
Phase 3

Conditions

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

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01854125
Jinling 01 (Other Identifier)
NanjingPLAGH1

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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:

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 3 patient groups

autologous bone marrow mesenchymal stem cells transplantation
Active Comparator group
Description:
Every patient is given 1x106 MSCs per kg infused via liver artery
Treatment:
Biological: autologous bone marrow msenchymal stem cells transplantation
Biological: autologous bone marrow mesenchymal stem cells transplantation
mesenchymal stem cells transplantation
Active Comparator group
Description:
autologous bone marrow mesenchymal stem cells transplantation
Treatment:
Biological: autologous bone marrow msenchymal stem cells transplantation
Biological: autologous bone marrow mesenchymal stem cells transplantation
stem cells transplantation
Experimental group
Description:
autologous bone marrow mesenchymal stem cells transplantation
Treatment:
Biological: autologous bone marrow msenchymal stem cells transplantation
Biological: autologous bone marrow mesenchymal stem cells transplantation

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems