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

Phase 1

• Conditions: Liver Transplantation
• Interventions: Biological: Mesenchymal Stem Cells(MSCs)

• Registration Number: NCT02706132
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary

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.

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 Timeline

• Study Start: 2014-02
• Status Verified: 2016-03
• Study First Submitted: 2016-03-08
• Study First Submitted QC: 2016-03-08
• Last Update Submitted: 2016-03-08
• Study First Posted: 2016-03-11
• Last Update Posted: 2016-03-11
• Primary Completion: 2016-12
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The MSCs group	Mesenchymal Stem Cells(MSCs)	The group of patients receive allogeneic MSCs therapies.

Primary Outcome Measures

Name	Time	Method
Efficacy: one year graft survival rate	one year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Third Affiliated Hospital,Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China