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

Sun Yat-sen University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Liver Transplantation

Treatments: Biological: Mesenchymal Stem Cells(MSCs)

Study type: Interventional

Funder types: Other

Identifiers

NCT02706132

2015-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

The MSCs group

Experimental group

Description:

The group of patients receive allogeneic MSCs therapies.

Treatment:

Biological: Mesenchymal Stem Cells(MSCs)