Overview

This trial is active, not recruiting.

Condition liver failure
Treatments group 1, group 2, group 3
Phase phase 2
Sponsor Sun Yat-sen University
Start date March 2011
End date November 2011
Trial size 120 participants
Trial identifier NCT01322906, ABMS-LF

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Thirty of the enrolled patients were assigned to Group A to receive comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.
group 1
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 2
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 3
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).

Primary Outcomes

Measure
Liver Function
time frame: 12months
Immune state
time frame: 12months

Eligibility Criteria

Male or female participants from 16 years up to 65 years old.

Inclusion Criteria: - Liver failure caused by HBV - Model for End-Stage Liver Disease (MELD) < 30 Exclusion Criteria: - 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.

Additional Information

Official title Allogeneic Bone Marrow Mesenchymal Stem Cells Transplantation in Patients With Liver Failure Caused by HBV
Trial information was received from ClinicalTrials.gov and was last updated in April 2011.
Information provided to ClinicalTrials.gov by Sun Yat-sen University.