Clinical trial NCT02706132: Therapeutic Strategy and the Role of Mesenchymal Stromal Cells for ABO Incompatible Liver Transplantation
Official title: MSC for ABO Incompatible Liver Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Liver Transplantation
Keywords: Mesenchymal stromal cells
Liver Transplantation
ABO blood group
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2016-03-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy: one year graft survival rate
timeFrame: one year
Secondary outcomes:
measure: the rate of acute rejection
timeFrame: one year
measure: the rate of ischemic-type biliary lesions
timeFrame: one year
measure: safety: rate of (serious) adverse events in the study population
timeFrame: one year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Third Affiliated Hospital,Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Yang Yang
role: STUDY_CHAIR
References: