Safety and Efficacy of Human Autologous Peripheral Blood 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; Other: PBSC transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT01728688

20120912-2

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.

In preclinical studies the investigators have demonstrated that G-CSF mobilized PBSC from patients with HBV related liver cirrhosis could differentiate into functional hepatocyte and autologous PBSC transplantation can significantly improve liver synthetic function. But further studied was needed to confirm the safety and efficacy of PBSC transplantation. In this study, a prospective, randomized, parallel clinical study was designed. The patients with HBV-related liver cirrhosis will undergo administration of human autologous PBSCs via hepatic artery to evaluate the safety and efficacy of human autologous PBSCs 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.the heart,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

Active Comparator group

Description:

conventional treatment \& antiviral treatment

Treatment:

Other: conventional treatment

conventional & PBSC transplantation

Experimental group

Description:

After three days G-CSF mobilization, Patients randomized to the intervention arm will receive autologous PBSCs transplantation at day1, and receive conventional treatment and antiviral treatment through the one year study visit and followed until one years study visit.

Treatment:

Other: PBSC transplantation