UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016851 |
|---|---|
| Receipt number | 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 23:23:31 |
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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
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
yukasan@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019004
