UMIN-CTR Clinical Trial

Basic information
Public title	Adoptive immunotherapy using donor liver graft derived natural killer (NK) cells for preventing severe infection after liver transplantation
Acronym	Liver NK cell therapy for preventing infection after liver transplant
Scientific Title	Adoptive immunotherapy using donor liver graft derived natural killer (NK) cells for preventing severe infection after liver transplantation
Scientific Title:Acronym	Liver NK cell therapy for preventing infection after liver transplant
Region	Japan

Condition
Condition	decompensated liver cirrhosis patients who will receive liver transplantation
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective is to analyze the safety and efficacy of adoptive immunotherapy using donor liver derived natural killer (NK) cells for preventing severe infection after liver transplantation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of blood stream infection during one month after liver transplantation
Key secondary outcomes	1. Overall survival (6 months, 1 and 3 years) 2. Effect on immunological reaponse after liver transplantation 3. Incidence of recurrence of hepatocellular carcinoma and de novo malignancy 4. Incidence of other infectious disease 5. Safety evaluation

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Single infusion of donor liver graft derived NK cells to the recipient 3 days after liver trasplantation
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Recipient 1) decompensated liver cirrhotic patients who will receive liver transplantation 2) 20 years old or older 3) written informed consent from patients or legal guardian Donor 1) healthy person who will receive living donor liver operation 2) 20 years old or older 3) written informed consent
Key exclusion criteria	1) patients who will receive re-transplantation 2) patients who will receive deceased donor liver transplantation
Target sample size	37

Research contact person
Name of lead principal investigator	1st name Hideki Middle name Last name Ohdan
Organization	Applied Life Sciences Institute of Biomedical and Health Sciences Hiroshima University
Division name	Department of Gastroenterological and Transplant Surgery
Zip code	734-8551
Address	1-2-3 Kasumi Minami-ku, Hiroshima city
TEL	082-257-5220
Email	hohdan@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Masahiro Middle name Last name Ohira
Organization	Hiroshima University Hospital
Division name	Medical Center for Translational and Clinical Research
Zip code	734-8551
Address	1-2-3 Kasumi Minami-ku, Hiroshima city
TEL	082-257-5222
Homepage URL
Email	mohira@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

Funding Source
Organization	Hiroshima University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hiroshima University Committee for Regenerative Medicine
Address	1-2-3 Kasumi, Minami-ku, Hiroshima city
Tel	082-257-5186
Email	kasumi-kenkyu@office.hiroshima-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	広島大学病院

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 09 Month 30 Day
Date of IRB	2015 Year 09 Month 30 Day
Anticipated trial start date	2015 Year 11 Month 25 Day
Last follow-up date	2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 09 Month 30 Day
Last modified on	2019 Year 10 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022074