Safety and Efficacy of Human Bone Marrow 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.
stem cells(SCs) possess plasticity and have the potential to differentiate into hepatocyte; Thus, SCs hold great hope for therapeutic applications. Adult bone marrow is the most common source of SCs for clinical applications.Previous study showed that bone marrow derived stem cells (BMSCs) replace hepatocytes in injured liver, and effectively rescue experimental liver failure and contribute to liver regeneration. In this study, the patients with HBV-related liver cirrhosis will undergo administration of human autologous BMSCs via hepatic artery to evaluate the safty and efficacy of human autologous BMSCs treatment for these patients.
|Liver Cirrhosis End Stage Liver Disease||Other: BMSC transplantation Other: conventional treatment & antivrial 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 Bone Marrow 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, 9 months and 1year after treatment ]
- AFP [ Time Frame: 1week, 4weeks, 3months, 6months, 9 months and 1year after treatment ]
- renal function [ Time Frame: 1week, 4weeks, 3months, 6months, 9 months and 1year after treatment ]
- child score [ Time Frame: 1week, 4weeks, 3months, 6months, 9 months 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 treatment
conventional treatment & antivrial treatment.
Other: conventional treatment & antivrial treatment
Participants will recieve conventional treatment and antivrial treatment.
Experimental: BMSC transplantation
conventional treatment & antiviral treatment & autologous bone marrow stem cell transplantation via hepatic artery
Other: BMSC transplantation
Patients randomized to the intervention arm will be collected for bone marrow stem cells and then infused with these cells via hepatic artery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01724697
|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|