UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory Research for the induction of natural killer cell propagated from G-CSF mobilized hematopoietic stem cells that were collected by apheresis method
Title of the study (Brief title)	Exploratory Research for the induction of NK cell propagated from hematopoietic stem cells in peripheral blood
Region	Japan

Condition
Condition	hapatocellular carcinoma
Classification by specialty	Hepato-biliary-pancreatic surgery Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We evaluate the induction efficiency of natural killer cells from G-CSF mobilized hematopoietic stem cells collected by apheresis in peripheral blood.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The number of NK cell from hematopoietic stem cell
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	G-CSF and apheresis
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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	(a) Healthy volunteer who agreed the purpose of this research (b) more than 20 years old or less than 70years old (c) The person who can come to this hospital continuously as per the time interval mentioned in the protocol (d) Informed consent must be taken.
Key exclusion criteria	(a) The person who suffered allergic reaction from the material of GRAN or other G-CSF (b) The level of blood test as mentioned below. Hgb: less than 12 (female), or 13 (male) WBC: less than 3000 /mm^3 Neutrophil:less than 1500 /mm^3 Platelet: less than 100 x 10^3 /mm^3 Biochemical test as mentioned below. AST, ALT, T-Bil, ALP, g-GTP, LDH, Total protein, Alb, T-chol, BUN, Cr, Na, K, Cl, Uric acid and CRP: more than standard level (c) The people who can stop drinking during injection of G-CSF (d) The breast feeding mother or pregnantlady (e) The doctor's disagrement for the registration due to some underlying medical conditon
Target sample size	3

Research contact person
Name of lead principal investigator	Hideki Ohdan
Organization	Hirohshima university
Division name	Department of Gastroenterological and Transplant Surgery
Address	1-2-3, Kasumi, Minami-ku, Hiroshima, Japan
TEL	082-257-5220
Email	hohdan@hiroshima-u.ac.jp

Public contact
Name of contact person	Yuka Tanaka
Organization	Hirohshima university
Division name	Department of Gastroenterological and Transplant Surgery
Address	1-2-3, Kasumi, Minami-ku, Hiroshima, Japan
TEL	082-257-5222
Homepage URL
Email	yukasan@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima university
Institute
Department

Funding Source
Organization	This study was funded by a Research on Hepatitis and BSE grant from the Japanese Ministry of Health, Labor and Welfare.
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

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

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 20 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 03 Month 13 Day
Anticipated trial start date	2015 Year 03 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 03 Month 20 Day
Last modified on	2018 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019004