Allogenic Bone Marrow Stem Cell Transplantation in Liver Failure

NCT01221454 | Unknown Phase 2 DMC

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

Brief Summary

The purpose of this study is to evaluate the therapeutic efficacy of allogenic bone marrow stem cells (BMSCs) transplantation in patients with liver failure caused by hepatitis B 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), liver histological improvement before and 1 week to 1 year after transplantation. Child-Pugh scores, MELD scores and clinical symptoms were also observed simultaneously.

Conditions

Liver Failure

Keywords

ABMSC; Allogenic bone marrow mesenchymal stem cells; Liver Failure; Transplantation

Outcome Measures

Primary Outcomes (1)

• Liver Function

  The levels of serum alanine aminotransferase (ALT), total bilirubin (TB),prothrombin time (PT), albumin (ALB), prealbumin(PA), number of leucocyte,erythrocyte and platelet, cytokines, T lymphocyte and B lymphocyte,liver histological

  12 months

Secondary Outcomes (1)

• Immune function

  12 months

Study Arms (2)

Group A(conserved therapy )

ACTIVE COMPARATOR

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

Drug: Conserved therapy

Group B (BMSC Transplantion)

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

Procedure: Allogenic bone marrow stem cells transplantation

Interventions

Allogenic bone marrow stem cells transplantation PROCEDURE

30ml allogenic bone marrow stem cells were infused to patients using interventional method via portal vein or hepatic artery as well as conserved therapy

Group B (BMSC Transplantion)

Conserved therapy DRUG

Oral or intravenous administration

Group A(conserved therapy )

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 16\~65 years.
• Serum HBsAg positive for over six months.
• Meet the diagnostic criteria of liver failure:

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 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location

Related Links

• The Third Affiliated Hospital of Sun Yat-sen University

MeSH Terms

Conditions

Liver Failure

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

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 12, 2010
• First Posted: October 15, 2010
• Study Start: October 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: October 18, 2010

Record last verified: 2010-10

Locations

CN (1)