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

Phase 1

• Conditions: Liver Cirrhosis; End Stage Liver Disease
• Interventions: Other: conventional treatment & antivrial treatment; Other: BMSC transplantation

• Registration Number: NCT01724697
• Lead Sponsor: Air Force Military Medical University, China

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-10-31
• Status Verified: 2012-11
• Study First Submitted QC: 2012-11-07
• Last Update Submitted: 2012-11-07
• Study First Posted: 2012-11-12
• Last Update Posted: 2012-11-12
• Primary Completion: 2014-09
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Aged 18-65 years
2. HBV-related liver cirrhosis
3. Child-Pugh score 9-15
4. Written consent

Exclusion Criteria

1. Hepatocellular carcinoma or other malignancies
2. Severe problems in other vital organs(e.g.theheart,renal or lungs)
3. Pregnant or lactating women
4. Severe bacteria infection
5. Anticipated with difficulty of follow-up observation
6. Other candidates who are judged to be not applicable to this study by doctors

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional treatment	conventional treatment & antivrial treatment	conventional treatment \& antivrial treatment.
BMSC transplantation	BMSC transplantation	conventional treatment \& antiviral treatment \& autologous bone marrow stem cell transplantation via hepatic artery

Primary Outcome Measures

Name	Time	Method
one year survival rate	one year after treatment

Secondary Outcome Measures

Name	Time	Method
AFP	1week, 4weeks, 3months, 6months, 9 months and 1year after treatment
MELD score	1week, 4weeks, 3months, 6months, 9 months and 1year after treatment
renal function	1week, 4weeks, 3months, 6months, 9 months and 1year after treatment
child score	1week, 4weeks, 3months, 6months, 9 months and 1year after treatment

Trial Locations

Locations (1)

Xijing Hospital of Digestive Disease; 🇨🇳 Xi'an, Shaanxi, China