Clinical trial NCT01728688: Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis
Official title: Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Liver Cirrhosis
End Stage Liver Disease
Keywords: liver cirrhosis
stem cell
peripheral blood
autologous
HBV
end stage liver disease
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
Collaborators: name: The Second Affiliated Hospital of Chongqing Medical University
name: Eastern Hepatobiliary Surgery Hospital
name: Chinese Academy of Medical Sciences
name: Fudan University
First posted: 2012-11-20
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 -

Primary outcomes:
measure: one-year survival rate
timeFrame: one year after treatment
Secondary outcomes:
measure: MELD score
timeFrame: 1week, 4weeks,3months, 6months, 9months and 1year after treatment
measure: Child Pugh Score
timeFrame: 1week, 4weeks,3months, 6months, 9months and 1year after treatment
measure: alpha fetoprotein
timeFrame: 1week, 4weeks,3months, 6months, 9months and 1year after treatment
measure: renal function
timeFrame: 1week, 4weeks,3months, 6months, 9months and 1year after treatment
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Disease
state: Shaanxi
Study officials:
affiliation: Air Force Military Medical University, China
name: Daiming Fan
role: STUDY_CHAIR
References: