Bone Mesenchymal Stem Cell (BMSC) Transplantation in Liver Cirrhosis Via Portal Vein

Sun Yat-sen University

Status and phase: Unknown; Phase 2

Conditions: Liver Cirrhosis

Treatments: Procedure: Autologous BMSCs transplantation; Drug: Conserved therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00993941

1-Bingliang

Details and patient eligibility

About

The objective of this study is to evaluate the therapeutic efficacy of autologous bone marrow mesenchymal stem cells (BMSCs) transplantation via portal vein in patients with early and middle stage of liver cirrhosis on the basis of HBV infection. 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18~60 years.
• Serum HBsAg positive.
• 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 less than 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Group A(conserved therapy )

Active Comparator group

Description:

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

Treatment:

Drug: Conserved therapy

Group B (BMSC Transplantion)

Experimental group

Description:

Thirty of the enrolled patients were randomly assigned to Group B were received comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine, as well as Bone Mesenchymal Stem Cells(BMSC) transplantation via portal vein.

Treatment:

Procedure: Autologous BMSCs transplantation