NCT01724697

Safety and Efficacy of Human Bone Marrow Stem Cells for Treatment of HBV-related Liver Cirrhosis

Safety and Efficacy of Human Autologous Bone Marrow Stem Cells for Treatment of HBV-related Liver Cirrhosis

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Air Force Military Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Liver Cirrhosis
• End Stage Liver Disease

Interventions

Type	Name	Description
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.
OTHER	conventional treatment & antivrial treatment	Participants will recieve conventional treatment and antivrial treatment.

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-09-01
• Completion: 2015-09-01
• First posted: 2012-11-12
• Last updated: 2012-11-12

Locations

1 site across 1 country: China