Allogenic Bone Marrow Stem Cells Transplantation in Patients With Liver Cirrhosis

Sponsor

Sun Yat-sen University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01223664

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Liver Cirrhosis	Procedure: Allogenic bone marrow stem cells transplantation Drug: Conserved therapy	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Efficacy of Allogenic Bone Marrow Stem Cells Transplantation in Patients With Liver Cirrhosis Resulting From Chronic Hepatitis B

Study Start Date :

Oct 1, 2010

Anticipated Primary Completion Date :

Nov 1, 2011

Anticipated Study Completion Date :

Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A(conserved therapy ) Thirty of the enrolled patients were assigned to Group A were received comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.	Drug: Conserved therapy Oral or intravenous administration
Experimental: Group B (BMSC Transplantion) 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	Procedure: 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

Arm

Intervention/Treatment

Active Comparator: Group A(conserved therapy )

Thirty of the enrolled patients were assigned to Group A were received comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.

Drug: Conserved therapy

Oral or intravenous administration

Experimental: Group B (BMSC Transplantion)

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

Procedure: 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

Outcome Measures

Primary Outcome Measures

Liver Function [12 months]

Secondary Outcome Measures

Immunity [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.