Clinical trial · Interventional
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
NCT01147380CI-TRIAL-00021292MIAMINKcompletedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Evidence of Liver Transplantation | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Cirrhosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liver NK cell inoculation | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Small dose
- description
- 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.
- interventionNames
- Biological: Liver NK cell inoculation
- type
- EXPERIMENTAL
- label
- Large dose
- description
- 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.
- interventionNames
- Biological: Liver NK cell inoculation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 * 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
References
Publications (1)
- DERIVEDOhira M, Hotta R, Tanaka Y, Matsuura T, Tekin A, Selvaggi G, Vianna R, Ricordi C, Ruiz P, Nishida S, Tzakis AG, Ohdan H. Pilot study to determine the safety and feasibility of deceased donor liver natural killer cell infusion to liver transplant recipients with hepatocellular carcinoma. Cancer Immunol Immunother. 2022 Mar;71(3):589-599. doi: 10.1007/s00262-021-03005-3. Epub 2021 Jul 19. PMID 34282496