Overview

This trial is active, not recruiting.

Condition liver cirrhosis
Treatments allogenic bone marrow stem cells transplantation, conserved therapy
Phase phase 2
Sponsor Sun Yat-sen University
Start date October 2010
End date November 2011
Trial size 60 participants
Trial identifier NCT01223664, SYS-1012

Summary

The objective of this study is to evaluate the therapeutic efficacy of allogenic bone marrow stem cells (BMSCs) transplantation in patients with liver cirrhosis. The evaluation of the efficacy includes the level of serum alanine aminotransferase (ALT), aspartate aminotransferase(AST), total bilirubin (TB),prothrombin time (PT), albumin (ALB), prealbumin(PA), precollagenⅢ(PCⅢ), collagenⅣ(Ⅳ-C), laminin(LN), hyaluronidase(HN), liver histological improvement before and 1 week to 1 year after transplantation. Child-Pugh scores and clinical symptoms were also observed simultaneously.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Thirty of the enrolled patients were assigned to Group A were received comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.
conserved therapy
Oral or intravenous administration
(Experimental)
Thirty of the enrolled patients were assigned to Group B to receive comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine, as well as bone marrow stem cells transplantation
allogenic bone marrow stem cells transplantation
30ml allogenic bone marrow stem cells were infused to patients using interventional method via portal vein or hepatic artery as well as conserved therapy

Primary Outcomes

Measure
Liver Function
time frame: 12 months

Secondary Outcomes

Measure
Immunity
time frame: 12 months

Eligibility Criteria

Male or female participants from 16 years up to 65 years old.

Inclusion Criteria: - Aged 16~65 years. - Serum HBsAg positive for over six months. - Ultrasonographic evidences of cirrhosis Exclusion Criteria: - History of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrolment. - Prothrombin time is over 30s. - Cirrhosis caused by other reasons except HBV infection. - 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.

Additional Information

Official title The Efficacy of Allogenic Bone Marrow Stem Cells Transplantation in Patients With Liver Cirrhosis Resulting From Chronic Hepatitis B
Principal investigator Lin B Liang, MD/PHD
Trial information was received from ClinicalTrials.gov and was last updated in October 2010.
Information provided to ClinicalTrials.gov by Sun Yat-sen University.