Safety and Efficacy of Diverse Mesenchymal Stem Cells Transplantation for Liver Failure

July 4, 2013 updated by: Qi Zhang, MD, Third Affiliated Hospital, Sun Yat-Sen University

Clinical Comparison of Safety and Efficacy of Allogeneic Umbilical-Cord and Bone Marrow-derived Mesenchymal Stem Cells Transplantation for HBV-related Liver Failure

HBV-related liver failure (HBV-LF), a dramatic clinical syndrome, is characterized with massive necrosis of liver cells. Liver transplantation might be the most effective therapy for HBV-LF. However, there are a lot of problems such as lack of donors, surgical complications, transplant rejection, and high cost, which could limit the application of liver transplantation. It is demonstrated that mesenchymal stem cells could directionally differentiate into hepatocytes and cholangiocytes in injured liver, as well as reduce inflammation of the liver by immune regulation. In this study, we assess the safety and efficacy of human bone marrow and umbilical cord mesenchymal stem cells transplantation for patients with HBV-LF.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

210

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 Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • Qi Zhang
        • Principal Investigator:
          • Qi Zhang, Doctor

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18-65 years
  • Liver failure
  • Negative pregnancy test (female patients in fertile age)
  • Written consent
  • HBsAg positive
  • TB≥171 μmol/L or ascend ≥17.1 μmol/L/per day,
  • INR≥1.5 or 20%<PTA≤40%
  • 17≤MELD score≤30

Exclusion Criteria:

  • Hepatocellular carcinoma or other malignancies
  • Severe problems in other vital organs(e.g.the heart,renal or lungs)
  • Pregnant or lactating women
  • Severe bacteria infection
  • Anticipated with difficulty of follow-up observation
  • Liver failure caused by other reasons, such as autoimmune diseases, alcohol, drug and so on
  • Other candidates who are judged to be not applicable to this study by doctors

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 72 study visit.
Drug: Conventional treatment

Received conventional treatment including:

A.antiviral drugs(Entecavir,Lamivudine,Adefovir dipivoxil,et al); B.Hepatoprotective drugs(Ademetionine1,4-butanethiosulfonate for Injection, Reduced Glutathione for Injection,Polyene Phosphatidylcholine, et al); C.Plasma.

Other Names:
  • Antiviral drugs
  • Hepatoprotective drugs
  • Plasma
Experimental: Conventional plus BM-MSC treatment
Participants will receive conventional treatment plus a dose of BM-MSC(each subgroups with a different dose ) and then be followed until the week 72 study visit.
Genetic: Conventional plus BM-MSC treatment
Received conventional treatment and bone marrow mesenchymal stem cells transplantation by peripheral vein slowly for 30minutes. (1×10e5/Kg,1×10e6/Kg,or 1×10e7/Kg, once a week, 8 times).
Experimental: Conventional plus UC-MSC treatment
Participants will receive conventional treatment plus a dose of UC-MSC(each subgroups with a different dose ) and then be followed until the week 72 study visit.
Genetic: Conventional plus UC-MSC treatment
Received conventional treatment and bone marrow mesenchymal stem cells transplantation by peripheral vein slowly for 30minutes. (1×10e5/Kg,1×10e6/Kg,or 1×10e7/Kg, once a week, 8 times)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival rate
Time Frame: 72 weeks
The survival rate and time
72 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver function
Time Frame: 72 weeks after treatment
The levels of serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST),Cholinesterase (CHE) ,Total Bilirubin(TB),Direct Bilirubin(DB), Serum Albumin （ALB）
72 weeks after treatment
Marker of liver cancer
Time Frame: 72 weeks after treatment
The level of alpha-fetoprotein (AFP)
72 weeks after treatment
The degree of hepatic necrosis
Time Frame: 2 years after treatment
The levels of Prothrombin Activity (PA) and Prothrombin Time (PT)
2 years after treatment
The improvement of symptoms
Time Frame: 72 weeks after treatment
The improvement of clinical symptoms [including appetite, debilitation, abdominal distension, edema of lower limbs, et al
72 weeks after treatment
The score for Model for End-Stage Liver Disease
Time Frame: 72 weeks after treatment
72 weeks after treatment
The improvement of immune function
Time Frame: 72 weeks after treatment
cluster of differentiation 4 (CD4+)T/ cluster of differentiation 8 (CD8+)T,T helper cell 1 (Th1)/ T helper cell 1(Th2),natural killer cell(NK),natural killer T(NK T),interleukin-1β(IL-1β),interleukin-4(IL-4),interleukin-6(IL-6),interleukin-8(IL-8),interleukin-12(IL-12),interleukin-15(IL-15),interleukin-17A(IL-17A),Tumor necrosis factor-alpha (TNF-α),Interferon-gamma (IFN-γ)
72 weeks after treatment
complications
Time Frame: Between 0 to 8 hours after MSC transfusion
The occurrence of complications [including body temperature, tetter and allergy]
Between 0 to 8 hours after MSC transfusion
The incidence of hepatocellular carcinoma
Time Frame: 72 weeks after treatment
72 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: Qi Zhang, Doctor, Third Affiliated Hospital, Sun Yat-Sen University

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

July 1, 2013

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

April 20, 2013

First Submitted That Met QC Criteria

April 27, 2013

First Posted (Estimate)

May 1, 2013

Study Record Updates

Last Update Posted (Estimate)

July 8, 2013

Last Update Submitted That Met QC Criteria

July 4, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The Third Affiliated Hospital

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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