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

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.

Study Overview

• Status: Unknown
• Conditions: End Stage Liver Disease; Liver Cirrhosis
• Intervention / Treatment: Other: conventional treatment; Other: UC-MSC transplantation

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital of Digestive Disease
      • Contact: Ying Han; Phone Number: 86-29-84771539; Email: hanying@fmmu.edu.cn
      • Contact: Yongquan Shi; Phone Number: 86-29-84771515; Email: shiyquan@fmmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventional; conventional treatment & antiviral treatment	Other: conventional treatment; Participants will receive conventional treatment and antiviral treatment.
Experimental: 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	Other: UC-MSC transplantation; After enrolled, Participant will receive umbilical cord MSC transplantation of 1*10E6 cells/kg via hepatic artery. Participant will then be followed until 1 years study visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
one year survival rate	one year after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China
• Collaborators: Fudan University; Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Eastern Hepatobiliary Surgery Hospital; The Second Affiliated Hospital of Chongqing Medical University
• Investigators: Study Chair: Daiming Fan, Air Force Military Medical University, China

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): September 1, 2014
• Study Completion (Anticipated): September 1, 2015

Study Registration Dates

• First Submitted: October 31, 2012
• First Submitted That Met QC Criteria: November 13, 2012
• First Posted (Estimate): November 20, 2012

Study Record Updates

• Last Update Posted (Estimate): November 20, 2012
• Last Update Submitted That Met QC Criteria: November 13, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: HBV; mesenchymal stem cells; liver cirrhosis; umbilical cord; end stage liver disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Pathologic Processes; Liver Diseases; End Stage Liver Disease; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: 20120912-3