Neoplasms

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Carcinoma

Carcinoma, Hepatocellular

Liver Cirrhosis

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Fibrosis

All Drugs and Chemicals

Hematinics

Immunomodulating Agents

Liver Extracts

From the donor liver perfusate, mononuclear cell will be extracted and cultured. Then, the cells will be stimulated with IL-2. The number of inoculation cells( mainly NK cells) is between 10 and 100 million cells. The cells will be given to the liver transplant recipient who had the same donor for liver and liver perfusate. Patient of this arm receive small dose of liver NK cell inoculation as described.

From the donor liver perfusate, mononuclear cell will be extracted and cultured. Then, the cells will be stimulated with IL-2. The number of inoculation cells(mainly NK cells) is between 100 and 1000 million cells. The cells will be given to the liver transplant recipient who had the same donor for liver and liver perfusate.Patient of this arm receive large dose of liver NK cell inoculation as described.

Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation.

Liver NK cell inoculation

Seigo Nishida, MD PhD

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.

Safety Study of Liver Natural Killer Cell Therapy for Hepatoma Liver Transplantation

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

Side effect of cadaveric donor liver NK cell infusion We will measure the occurence of the side effect of the liver NK cell infusion. We will monitor the patient condition clinically. If any side effect are noticed, we will record them and report to the data safety monitoring comittee.

To assess NK cell infusion -related toxicity at the bedside. We will monitor the patient and check the vital sign. If any side effect are noticed, we will record and report to the data safety monitoring comittee.

Florida Department of Health

Seigo Nishida

Professor of clinical surgery

Adverse events will be graded according to the Common terminology criteria for Adverse Events Guide.

A Data Safety Monitoring Committee will be constituted to analyze safety and preliminary evidence of efficacy of the trial.

Adverse events will be reported to the IRB and DSMB. Serious adverse events will be reported to the DSMB within 24 hours.

The number of inoculation cells is between 10 and 100 million cells.

Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation.

Small Dose

The number of inoculation cells is between 100 and 1000 million cells

Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation.

Large Dose

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr. Seigo Nishida

Side Effect of Cadaveric Donor Liver NK Cell Infusion

From the donor liver perfusate, mononuclear cell will be extracted and cultured. Then, the cells will be stimulated with IL-2. The number of inoculation cells( mainly NK cells) is between 10 and 100 million cells. The cells will be given to the liver transplant recipient who had the same donor for liver and liver perfusate. Patient of this arm receive small dose of liver NK cell inoculation as described.

Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation.

From the donor liver perfusate, mononuclear cell will be extracted and cultured. Then, the cells will be stimulated with IL-2. The number of inoculation cells(mainly NK cells) is between 100 and 1000 million cells. The cells will be given to the liver transplant recipient who had the same donor for liver and liver perfusate.Patient of this arm receive large dose of liver NK cell inoculation as described.

Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation.

Participants were devided two group( small and large dose) as described based on the dose of infused cell numbers.

NK Cell Infusion-related Toxicity

Anti-HCC Effect of This Treatment

Anti-HCV Effect of This Treatment (If Applicable)

The number of inoculation cells is between 10 and 100 million cells.

Liver NK cell inoculation: Liver transplant recipients will receive liver NK cell inoculation several days after liver transplantation.

The number of inoculation cells is between 100 and 1000 million cells

Liver NK cell inoculation: Liver transplant recipients will receive liver NK cell inoculation several days after liver transplantation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety Study of Liver Natural Killer Cell Therapy for Hepatoma Liver Transplantation	NCT01147380	Liver Cirrhosis Hepatocellular ... Evidence of Liv...	Liver NK cell i...	18 Years -	University of Miami
Safety Study of Liver Natural Killer Cell Therapy for Hepatoma Liver Transplantation	NCT01147380	Liver Cirrhosis Hepatocellular ... Evidence of Liv...	Liver NK cell i...	18 Years -	University of Miami

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