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

NCT00993941 | Unknown Phase 2 DMC

• 1 other identifier: 1-Bingliang
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Cirrhosis

Keywords

BMSC; Stem cells; Liver cirrhosis; Transplantation

Outcome Measures

Primary Outcomes (1)

• The levels of serum alanine aminotransferase (ALT), total bilirubin (TB),prothrombin time (PT), albumin (ALB), prealbumin(PA), precollagenⅢ(PCⅢ), collagenⅣ(Ⅳ-C), laminin(LN), hyaluronidase(HN), liver histological improvement.

  pre-transplantation, and 1week to 1 year post-transplantation

Study Arms (2)

Group A(conserved therapy )

ACTIVE COMPARATOR

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

Drug: Conserved therapy

Group B (BMSC Transplantion)

EXPERIMENTAL

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.

Procedure: Autologous BMSCs transplantation

Interventions

Autologous BMSCs transplantation PROCEDURE

10 ml autologous BMSCs(7\~8log10 cells/ml) were infused to patients using interventional method via portal vein as well as conserved therapy for group B.

Group B (BMSC Transplantion)

Conserved therapy DRUG

Oral or intravenous administration

Group A(conserved therapy )

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18\~60 years.
• Serum HBsAg positive.
• Ultrasonographic evidences of cirrhosis.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lin B liang, MD/PHD

  SunYat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 13, 2009
• First Posted: October 14, 2009
• Study Start: October 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: April 1, 2011
• Last Updated: December 6, 2010

Record last verified: 2009-10

Locations

CN (1)