Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis
Recruitment status was: Recruiting
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.
|Liver Cirrhosis End Stage Liver Disease||Other: PBSC transplantation Other: conventional treatment||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis|
- one-year survival rate [ Time Frame: one year after treatment ]
- MELD score [ Time Frame: 1week, 4weeks,3months, 6months, 9months and 1year after treatment ]
- Child Pugh Score [ Time Frame: 1week, 4weeks,3months, 6months, 9months and 1year after treatment ]
- alpha fetoprotein [ Time Frame: 1week, 4weeks,3months, 6months, 9months and 1year after treatment ]
- renal function [ Time Frame: 1week, 4weeks,3months, 6months, 9months and 1year after treatment ]
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Conventional
conventional treatment & antiviral treatment
Other: conventional treatment
Participants will receive conventional treatment and antiviral treatment.
Experimental: conventional & PBSC transplantation
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.
Other: PBSC 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01728688
|Contact: Ying Hanemail@example.com|
|Contact: Yongquan Shifirstname.lastname@example.org|
|Xijing Hospital of Digestive Disease||Recruiting|
|Xi'an, Shaanxi, China, 710032|
|Contact: Ying Han 86-29-84771539 email@example.com|
|Contact: Yongquan Shi 86-29-84771515 firstname.lastname@example.org|
|Study Chair:||Daiming Fan||Fourth Military Medical University|