Safety and Efficacy of Human Umbilical Cord Derived Mesenchymal Stem Cells for Treatment of HBV-related Liver Cirrhosis

Phase 1

• Conditions: Liver Cirrhosis; End Stage Liver Disease
• Interventions: Other: UC-MSC transplantation; Other: conventional treatment

• Registration Number: NCT01728727
• 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.

Mesenchymal stem cells (MSCs) possess plasticity and have the potential to differentiate into hepatocyte; Thus, MSCs hold great hope for therapeutic applications. Human umbilical cord-derived MSCs (hUC-MSCs) exhibit a more beneficial immunogenic profile and greater overall immunosuppressive potential than aged bone marrow-derived MSCs. Like MSCs derived from bone marrow, hUC-MSCs can also be used to treat rat liver fibrosis and improve glucose homeostasis in rats with liver cirrhosis. In this study, the patients with HBV-related liver cirrhosis will undergo administration of hUC-MSCs via hepatic artery to evaluate the safety and efficacy of hUC-MSC 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: 2012-11-13
• Last Update Submitted: 2012-11-13
• Study First Posted: 2012-11-20
• Last Update Posted: 2012-11-20
• 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.the heart,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
UC-MSC transplantation	UC-MSC transplantation	Participants will receive umbilical cord derived mesenchymal stem cell treatment at day 1 and conventional treatment and antiviral treatment through the one year study visit. Participants will then be followed until one years study visit
conventional	conventional treatment	conventional treatment \& antiviral treatment

Primary Outcome Measures

Name	Time	Method
one year survival rate	one year after treatment

Secondary Outcome Measures

Name	Time	Method
MELD score	1week, 4weeks,3months, 6months, 9months and 1year after treatment
Child Pugh Score	1week, 4weeks,3months, 6months, 9months and 1year after treatment
alpha fetoprotein	1week, 4weeks,3months, 6months, 9months and 1year after treatment
renal function	1week, 4weeks,3months, 6months, 9months and 1year after treatment

Trial Locations

Locations (1)

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