Allogenic Bone Marrow Stem Cell Transplantation in Liver Failure

Sun Yat-sen University

Status and phase: Unknown; Phase 2

Conditions: Liver Failure

Treatments: Drug: Conserved therapy; Procedure: Allogenic bone marrow stem cells transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT01221454

SYS-LF

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Group A(conserved therapy )

Active Comparator 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:

Drug: Conserved therapy

Group B (BMSC Transplantion)

Experimental group

Description:

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

Treatment:

Procedure: Allogenic bone marrow stem cells transplantation