Therapeutic Strategy and the Role of Mesenchymal Stromal Cells for ABO Incompatible Liver Transplantation

March 8, 2016 updated by: Yang Yang, Third Affiliated Hospital, Sun Yat-Sen University

MSC for ABO Incompatible Liver Transplantation

The purpose of this study is to determine whether MSCs are safe and effective in reducing the primary nonfunction (PNF), acute rejection and Ischemic-type Biliary Lesions (ITBLs) morbidity in ABO-incompatible Liver Transplantation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

ABO incompatible liver transplantations is considered to be a rescue option in emergency transplantation.The A、B antibodies to grafts bind to the graft endothelium and activate complement, which attracts and activates neutrophils and platelets and increases the permeability of the endothelium. The neutrophils exude, the platelets aggregate, and the small vessels of the graft get thrombosed, resulting in ischemic damage,leading nonfunction grafts.In addition, if the A、 B antibodies remain high level, it can lead to acute humoral immune rejection. A lot of research confirmed that the ABO incompatible is a risk factor of postoperative short- and long-term survival. And mesenchymal stromal cells (MSCs) are characterized by the properties of immunosuppressive and regenerative properties, which make MSCs great attractive in treating immunological diseases (including transplant rejection) and organ/tissue ischemic injury. So we conduct this clinical study,to confirm the effect of MSCs in ABO incompatible liver transplantation by comparing the incidence of primary nonfunction, acute rejection, biliary complications and survival rates.

Study Type

Interventional

Enrollment (Anticipated)

15

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 Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • the Third Affiliated Hospital,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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • First liver transplantation with a ABO-incompatible graft(B→A，AB→A，A→B，AB→B，A→O，B→O，AB→O).
  • Ages of 18 or older.
  • Patients receive liver transplantation due to benign end stage liver disease.
  • Patients or legal agent must be able to give informed consent.

Exclusion Criteria:

  • Second or combined organ transplant recipient.
  • Combined transplantations such as simultaneous liver/kidney transplants
  • Malignant disease.
  • Uncontrol bacterial, fungal, viral or parasitic infection.
  • Withdraw or unable to finish the follow-up.
  • Unwilling to sign informed consent.

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The MSCs group
The group of patients receive allogeneic MSCs therapies.
Biological: Mesenchymal Stem Cells(MSCs)
Six doses of 1*10^6/kg body weight MSCs are given, intravenously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy: one year graft survival rate
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the rate of acute rejection
Time Frame: one year
one year
the rate of ischemic-type biliary lesions
Time Frame: one year
one year
safety: rate of (serious) adverse events in the study population
Time Frame: one year
adverse events include: allergic reaction, prothrombotic effects, opportunistic infections and malignancy
one year

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

  • Study Chair: Yang Yang, 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

February 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

March 8, 2016

First Submitted That Met QC Criteria

March 8, 2016

First Posted (Estimate)

March 11, 2016

Study Record Updates

Last Update Posted (Estimate)

March 11, 2016

Last Update Submitted That Met QC Criteria

March 8, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2015-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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