Safety and Efficacy of Human Bone Marrow Stem Cells for Treatment of HBV-related Liver Cirrhosis
|ClinicalTrials.gov Identifier: NCT01724697|
Recruitment Status : Unknown
Verified November 2012 by Han Ying, Fourth Military Medical University.
Recruitment status was: Recruiting
First Posted : November 12, 2012
Last Update Posted : November 12, 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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Liver Cirrhosis End Stage Liver Disease||Other: BMSC transplantation Other: conventional treatment & antivrial 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 Bone Marrow 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 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.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|