Know Cancer

forgot password

A Novel Immunotherapy for Liver Transplant Patients With Hepatocellular Carcinoma: Anti-tumor Effect of IL2-activated Donor Liver Natural Killer Cell

Phase 1
18 Years
Open (Enrolling)
Liver Cirrhosis, Hepatocellular Carcinoma, Liver Transplantation

Thank you

Trial Information

A Novel Immunotherapy for Liver Transplant Patients With Hepatocellular Carcinoma: Anti-tumor Effect of IL2-activated Donor Liver Natural Killer Cell

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

- Complete blood count; Platelet > 20,000 /mm3, Hematocrit > 20%, WBC > 1,000 /mm3

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the side effect of cadaveric donor liver NK cell infusion

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Seigo Nishida, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Surgery, University of Miami


United States: Food and Drug Administration

Study ID:




Start Date:

June 2010

Completion Date:

June 2015

Related Keywords:

  • Liver Cirrhosis
  • Hepatocellular Carcinoma
  • Liver Transplantation
  • Carcinoma
  • Liver Cirrhosis
  • Fibrosis
  • Carcinoma, Hepatocellular



University of Miami Miami, Florida  33136