Hepatocellular Carcinoma Clinical Trial
Official title:
A Novel Immunotherapy for Liver Transplant Patients With Hepatocellular Carcinoma: Anti-tumor Effect of IL2-activated Donor Liver Natural Killer Cell
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)
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 transplantation.
The method we plan to use is to collect NK cells from the cadaveric donor liver perfusate at
the time of organ recovery. The perfusate will be condensed by centrifuging and liver
mononuclear cells (LMNC) were isolated by gradient centrifugation. LMNC will be cultured
with anti-CD3 antibody. LMNC will be separted into a CD3-/CD56+ NK cell fraction and a
non-NK cell fraction. The purity of isolated fractions will be assessed by Flow cytometric
analyses. NK cells will be cultured with human recombinant IL-2 in 10% RPMI at 37 ºC in a 5%
CO2 incubator. NK cells will be infused intravenously to the recipient with HCC who have
liver transplant from the same cadaveric donor at post operative day 4 in attempt to prevent
the metastasis and recurrence of HCC.
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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