Status:
COMPLETED
Safety Study of Liver Natural Killer Cell Therapy for Hepatoma Liver Transplantation
Lead Sponsor:
Seigo Nishida
Collaborating Sponsors:
Florida Department of Health
Conditions:
Liver Cirrhosis
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 transpl...
Detailed Description
To investigate whether adoptive transfer of IL-2 stimulated NKcells extracted from cadaveric donor liver graft exudates into recipient with HCC will lead to prevent recurrence of HCC after liver trans...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01147380
Start Date
June 1 2010
End Date
December 1 2014
Last Update
March 10 2016
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33176