Allogeneic Bone Marrow Mesenchymal Stem Cells Transplantation in Patients With Liver Failure Caused by Hepatitis B Virus (HBV)

NCT01322906 | Unknown Phase 2 DMC

• 1 other identifier: ABMS-LF
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

Allogeneic Bone Marrow Mesenchymal Stem Cells Transplantation in Patients with Liver Failure Caused by hepatitis B virus (HBV)

Conditions

Liver Failure

Keywords

ABMLF; Allogenic Bone marrow Mesenchymal Stem Cells; Liver Failure; Transplantation

Outcome Measures

Primary Outcomes (2)

• Liver Function

  The levels of serum alanine aminotransferase (ALT), aspartate aminotransferase(AST),total bilirubin (TB),prothrombin time (PT), prothrombin activity(PTA),INR,albumin (ALB),globulin(GLB), prealbumin(PA),creatinine(Cr), Urea nitrogen(BUN),number of leucocyte,erythrocyte and platelet, cytokines,liver histological

  12months

• Immune state

  cytokine

  12months

Study Arms (1)

Group A

OTHER

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

Other: Group 1; Other: Group 2; Other: Group 3

Interventions

Group 1 OTHER

Thirty of the enrolled patients were assigned to Group B to receive comprehensive treatment, as well as allogeneic bone marrow mesenchymal stem cells transplantation by peripheral vein(2×105/Kg, once a week, 4 times).

Group A

Group 2 OTHER

Thirty of the enrolled patients were assigned to Group B to receive comprehensive treatment, as well as allogeneic bone marrow mesenchymal stem cells transplantation by peripheral vein(1×106/Kg, once a week, 4 times).

Group A

Group 3 OTHER

Thirty of the enrolled patients were assigned to Group B to receive comprehensive treatment, as well as allogeneic bone marrow mesenchymal stem cells transplantation by peripheral vein(5×106/Kg, once a week, 4 times).

Group A

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:

• Liver failure caused by HBV
• Model for End-Stage Liver Disease (MELD) \< 30

You may not qualify if:

• Liver Failure caused by other reasons, such as autoimmune diseases, alcohol, drug and so on.
• History of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrollment.
• Severe problems in other vital organs (e.g.the heart,renal or lungs).
• Tumor on ultrasonography, CT or MRI examination.
• Pregnant or lactating women.
• HIV infection.

Sponsors & Collaborators

• Sun Yat-sen University: lead

MeSH Terms

Conditions

Liver Failure

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Design

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

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: March 25, 2011
• Study Start: March 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: July 1, 2012
• Last Updated: April 11, 2011

Record last verified: 2010-10