Autologous Mesenchymal Stem Cell Transplantation in Cirrhosis Patients With Refractory Ascites

Characters of Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01854125
• Other study ID #: NanjingPLAGH1
• Secondary ID: Jinling 01
• Status: Unknown status
• Phase: Phase 3
• First received: May 12, 2013
• Last updated: May 14, 2013
• Start date: May 2013

Study information

• Verified date: May 2013
• Source: Nanjing PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 30
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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:

Related Conditions & MeSH terms

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

Intervention

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.
• autologous bone marrow msenchymal stem cells transplantation

Locations

Country	Name	City	State
China	Jinling Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing PLA General Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Kharaziha P, Hellström 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in immune function,liver function in blood		before and one to 12 weeks after therapy