Safety Study of Liver Natural Killer Cell Therapy for Hepatoma Liver Transplantation (NCT01147380) | Clinical Trial Compass
CompletedPhase 1
Safety Study of Liver Natural Killer Cell Therapy for Hepatoma Liver Transplantation
United States18 participantsStarted 2010-06
Plain-language 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)
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Transp…
What they're measuring
1
Side Effect of Cadaveric Donor Liver NK Cell Infusion