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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000016851
Receipt No. R000019004
Scientific Title Exploratory Research for the induction of natural killer cell propagated from G-CSF mobilized hematopoietic stem cells that were collected by apheresis method
Date of disclosure of the study information 2015/03/20
Last modified on 2018/06/12

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Basic information
Public title Exploratory Research for the induction of natural killer cell propagated from G-CSF mobilized hematopoietic stem cells that were collected by apheresis method
Acronym Exploratory Research for the induction of NK cell propagated from hematopoietic stem cells in peripheral blood
Scientific Title Exploratory Research for the induction of natural killer cell propagated from G-CSF mobilized hematopoietic stem cells that were collected by apheresis method
Scientific Title:Acronym 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
1st name
Middle name
Last name Hideki Ohdan
Organization Hirohshima university
Division name Department of Gastroenterological and Transplant Surgery
Zip code
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
1st name
Middle name
Last name Yuka Tanaka
Organization Hirohshima university
Division name Department of Gastroenterological and Transplant Surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Terminated
Date of protocol fixation
2015 Year 03 Month 13 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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