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

Sun Yat-sen University

Status and phase: Unknown; Phase 2

Conditions: Liver Failure

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01322906

ABMS-LF

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Group A

Other group

Description:

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

Treatment:

Other: Group 3

Other: Group 2

Other: Group 1