Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- one-year survival rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 18-65 years
- •HBV-related liver cirrhosis
- •Child-Pugh score 9-15
- •Written consent
Exclusion Criteria
- •Hepatocellular carcinoma or other malignancies
- •Severe problems in other vital organs(e.g.the heart,renal or lungs)
- •Pregnant or lactating women
- •Severe bacteria infection
- •Anticipated with difficulty of follow-up observation
- •Other candidates who are judged to be not applicable to this study by doctors -
Outcomes
Primary Outcomes
one-year survival rate
Time Frame: one year after treatment
Secondary Outcomes
- 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)
Investigators
Han Ying
professor
Air Force Military Medical University, China