Safety Study of Liver Natural Killer Cell Therapy for Hepatoma Liver Transplantation
Condition: Liver Cirrhosis; Hepatocellular Carcinoma; Evidence of Liver Transplantation
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Liver Cirrhosis
Intervention: Liver NK cell inoculation
Intervention description: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate feasibility and safety of the adoptive transfer of
      activated natural killer (NK) cells extracted from cadaveric donor liver graft perfusate for
      liver transplant recipients with hepatocellular carcinoma (HCC)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary liver transplant recipient with HCC

          -  Patients need to meet the liver transplant eligibility criteria

          -  Cardiac function; cardiac echo will indicate that ejection fraction (EF) > 35% or
             right ventricular systolic pressure (RVSP) < 50mmHg. Stress echo will show no ischemic
             lesion (if applicable).

          -  Pulmonary function; SpO2 >90% or PaO2 > 60 mmHg, or CT will show no active pulmonary
             lesion.

          -  Complete blood count; Platelet > 20,000 /mm^3, Hematocrit > 20%, WBC > 1,000 /mm^3

          -  Eighteen years of age or older

          -  Ability to provide informed consent

          -  If female of childbearing potential:

        Must not be lactating, must have a negative serum B-human chorionic gonadotropin (HCG) test
        within 7 days prior to Day of Transplant, and must agree to practice an acceptable and
        reliable form of contraception during the study Ability to provide informed consent

        Exclusion Criteria:

          -  Living donor liver transplant; a healthy person donates part of his or her liver to
             the recipient

          -  Multiple organ transplants

          -  Prior solid organ or bone marrow transplant recipients

          -  Fluminant hepatic failure

          -  The patients regularly receive the hemodialysis more than twice a week before liver
             transplant

          -  Status 1 transplants; acute severe disease and defined as a patient with only recent
             development of liver disease who is in the intensive care unit of the hospital with a
             life expectancy without a liver transplant of fewer than 7 days

          -  ABO incompatible transplants

          -  Transplants utilizing livers from non-heart beating donors; the cardiac death donor

          -  Recipients of investigational therapy within 90 days prior to transplant procedure

          -  Acute viral illness

          -  History of malignancy within 5 years, with exception of: Adequately treated localized
             squamous or basal cell carcinoma of the skin without evidence or recurrence, and/or
             Hepatocellular carcinoma

          -  Illness other than primary liver disease (e.g., severe ischemic heart disease, left
             ventricular dysfunction, or pulmonary disease), which, in the opinion of the
             Investigator, may significantly increase the risk of the transplantation procedure

          -  Current drug or alcohol abuse or, in the opinion of the Investigator, is at risk for
             poor compliance (no drug testing required)

          -  Serology positive donor (HCV, HBsAg, HBcAb, HTLV-1, HTLV-3, EBVIgM)

          -  Poor liver function donor (Total bilirubin > 3.0 mg/dl, Prothrombin time > 35 sec),

          -  Patients who receive intercurrent chemotherapy at the time of enrollment