Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01728688

Enrollment

240

Registered

2012-11-20

Start date

2012-09-30

Completion date

2015-09-30

Last updated

2012-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Liver Disease, Liver Cirrhosis

Keywords

liver cirrhosis, stem cell, peripheral blood, autologous, HBV, end stage liver disease

Brief summary

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.

Interventions

OTHERPBSC transplantation

PBSCs were mobilized with recombinant human G-CSF at 5-10ug/kg/d for three days. then PBSCs were collected by means of apheresis. The collected PBSCs were infused into participant via hepatic artery

OTHERconventional treatment

Participants will receive conventional treatment and antiviral treatment.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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 -

Design outcomes

Primary

Measure	Time frame
one-year survival rate	one year after treatment

Secondary

Measure	Time frame
MELD score	1week, 4weeks,3months, 6months, 9months and 1year after treatment
Child Pugh Score	1week, 4weeks,3months, 6months, 9months and 1year after treatment
alpha fetoprotein	1week, 4weeks,3months, 6months, 9months and 1year after treatment
renal function	1week, 4weeks,3months, 6months, 9months and 1year after treatment

Countries

China

Contacts

Primary ContactYing Han

hanying@fmmu.edu.cn86-29-84771539

Backup ContactYongquan Shi

shiyquan@fmmu.edu.cn86-29-84771515

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026