Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis
|ClinicalTrials.gov Identifier: NCT01728688|
Recruitment Status : Unknown
Verified November 2012 by Han Ying, Fourth Military Medical University.
Recruitment status was: Recruiting
First Posted : November 20, 2012
Last Update Posted : November 20, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Liver Cirrhosis End Stage Liver Disease||Other: PBSC transplantation Other: conventional treatment||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||September 2015|
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
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01728688
|Contact: Ying Hanfirstname.lastname@example.org|
|Contact: Yongquan Shiemail@example.com|
|Xijing Hospital of Digestive Disease||Recruiting|
|Xi'an, Shaanxi, China, 710032|
|Contact: Ying Han 86-29-84771539 firstname.lastname@example.org|
|Contact: Yongquan Shi 86-29-84771515 email@example.com|
|Study Chair:||Daiming Fan||Fourth Military Medical University|