Safety and Efficacy of Human Bone Marrow Stem Cells for Treatment of HBV-related Liver Cirrhosis

Air Force Military Medical University of People's Liberation Army

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Liver Cirrhosis; End Stage Liver Disease

Treatments: Other: conventional treatment & antivrial treatment; Other: BMSC transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT01724697

20120912-1

Details and patient eligibility

About

HBV related Liver disease is a common medical problem in China. An estimated 7.18% of the Chinese (about 93 million) is infected with hepatitis B, and most of the HBV- related hepatitis can developed into liver cirrhosis.

Liver transplantation is the only available life saving treatment for patients with end stage liver disease. However, lack of donors, surgical complications, rejection, and high cost are serious problems.

stem cells(SCs) possess plasticity and have the potential to differentiate into hepatocyte; Thus, SCs hold great hope for therapeutic applications. Adult bone marrow is the most common source of SCs for clinical applications.Previous study showed that bone marrow derived stem cells (BMSCs) replace hepatocytes in injured liver, and effectively rescue experimental liver failure and contribute to liver regeneration. In this study, the patients with HBV-related liver cirrhosis will undergo administration of human autologous BMSCs via hepatic artery to evaluate the safty and efficacy of human autologous BMSCs treatment for these patients.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 18-65 years
2. HBV-related liver cirrhosis
3. Child-Pugh score 9-15
4. Written consent

Exclusion criteria

1. Hepatocellular carcinoma or other malignancies
2. Severe problems in other vital organs(e.g.theheart,renal or lungs)
3. Pregnant or lactating women
4. Severe bacteria infection
5. Anticipated with difficulty of follow-up observation
6. Other candidates who are judged to be not applicable to this study by doctors

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

conventional treatment

Active Comparator group

Description:

conventional treatment \& antivrial treatment.

Treatment:

Other: conventional treatment & antivrial treatment

BMSC transplantation

Experimental group

Description:

conventional treatment \& antiviral treatment \& autologous bone marrow stem cell transplantation via hepatic artery

Treatment:

Other: BMSC transplantation