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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2017-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Liver Transplantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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The MSCs group

The group of patients receive allogeneic MSCs therapies.

Group Type EXPERIMENTAL

Mesenchymal Stem Cells(MSCs)

Intervention Type BIOLOGICAL

Six doses of 1\*10\^6/kg body weight MSCs are given, intravenously.

Interventions

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Mesenchymal Stem Cells(MSCs)

Six doses of 1\*10\^6/kg body weight MSCs are given, intravenously.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No