Umbilical Cord Mesenchymal Stem Cells Transplantation Combined With Plasma Exchange for Patients With Liver Failure

February 27, 2013 updated by: Zhiliang Gao, Third Affiliated Hospital, Sun Yat-Sen University

Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells Transplantation Combined With Plasma Exchange for Patients With Acute-on-Chronic Liver Failure Caused by Hepatitis B Virus (HBV)

Liver failure (LF) is a dramatic clinical syndrome with massive necrosis of liver cells. Although liver transplantation provides an option to cure patients suffering with LF, lack of donors, postoperative complications, especially rejection, and high cost limit its application. Previous study showed that bone marrow derived mesenchymal stem cells (BM-MSCs) the novel and promising therapeutic strategy, BM-MSCs can replace hepatocytes in injured liver, and effectively rescue experimental liver failure and contribute to liver regeneration. Plasma exchange (PE) can improve internal environment by removing endotoxin, it helps the liver regeneration and functional recovery and make UC-MSC differentiation into hepatocyte like cells, and exert immunomodulatory function. In this study, safety and efficacy of human umbilical cord mesenchymal stem cells (UC-MSCs) transplantation combined with plasma exchange (PE) for patients with liver failure caused by hepatitis B Virus will be evaluated.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To investigate safety and efficacy of human umbilical cord mesenchymal stem cells (UC-MSCs) transplantation combined with plasma exchange (PE) for patients with liver failure caused by hepatitis B virus.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent
  • Acute-on-Chronic liver failure caused by hepatitis B virus
  • Model for End-Stage Liver Disease (MELD) <30

Exclusion Criteria:

  • Liver failure caused by other reasons, such as autoimmune diseases, alcohol, drug and so on
  • History of severe hepatic encephalopathy or variceal bleeding during the last two months before enrollment
  • Severe problems in other vital organs(e.g. the heart, renal or lungs)
  • Severe bacteria infection
  • Tumor on ultrasonography, CT or MRI examination
  • Pregnant or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conventional treatment
Participants will receive conventional treatment and then be followed until the week 48 study visit.
Other: Conventional treatment
Received conventional treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.
Experimental: Conventional plus UC-MSC treatment
Participants will receive conventional treatment plus a dose of UC-MSC and then be followed until the week 48 study visit.
Other: Conventional plus UC-MSC treatment
Received conventional treatment and umbilical cord mesenchymal stem cells transplantation by peripheral vein slowly for 30minutes. (1×105/Kg, once a week, 4 times).
Experimental: Conventional plus PE treatment
Participants will receive conventional treatment plus plasma exchange and then be followed until the week 48 study visit.
Other: Conventional plus PE treatment
Received conventional treatment plus 2000 milliliter plasma exchange (every 3 days, 3 times).
Experimental: Conventional plus UC-MSC and PE therapy
Participants will receive conventional treatment plus umbilical cord mesenchymal stem cells transplantation combined with plasma exchange. Participants will then be followed until the week 48 study visit.
Other: Conventional plus UC-MSC and PE therapy
Received conventional treatment plus 2000 milliliter plasma exchange (every 3 days, 3 times). Meantime taken i.v umbilical cord mesenchymal stem cells transplantation slowly for 30minutes (1×105/Kg, once a week, 4 times), the first two times is taken after plasma exchange.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival rate and time
Time Frame: 48 weeks
48 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Improve biochemical indexes [alanine aminotransferase (ALT), albumin (ALB), total bilirubin (TBIL), prothrombin time (PT), INR and so on]
Time Frame: 24 weeks after treatment
24 weeks after treatment
The clinical symptom improvement [including appetite, debilitation, abdominal distension, edema of lower limbs, et al]
Time Frame: 24 weeks after treatment
24 weeks after treatment
Liver function evaluation using Child-Pugh score and MELD score
Time Frame: 24 weeks after treatment
24 weeks after treatment
Immune function improvement [including Th1/Th2]
Time Frame: 24 weeks after treatment
24 weeks after treatment
The occurrence of complications [including body temperature, tetter and allergy]
Time Frame: Between 0 to 8 hours after UC-MSCs transfusion
Between 0 to 8 hours after UC-MSCs transfusion
Incidence of hepatocellular carcinoma
Time Frame: 48 weeks after treatment
48 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Investigators

  • Principal Investigator: Zhi-Liang Gao, Doctor, The Third Affliated Hospital of Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Anticipated)

March 1, 2015

Study Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

November 4, 2012

First Submitted That Met QC Criteria

November 6, 2012

First Posted (Estimate)

November 9, 2012

Study Record Updates

Last Update Posted (Estimate)

February 28, 2013

Last Update Submitted That Met QC Criteria

February 27, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCMSC-PE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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