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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038311
Receipt No. R000043665
Scientific Title A trial of induced differentiation of humanmemory lymphocytes in vitro
Date of disclosure of the study information 2019/10/17
Last modified on 2020/10/16

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Basic information
Public title A trial of induced differentiation of humanmemory lymphocytes in vitro
Acronym A trial of induced differentiation of humanmemory lymphocytes in vitro
Scientific Title A trial of induced differentiation of humanmemory lymphocytes in vitro
Scientific Title:Acronym A trial of induced differentiation of humanmemory lymphocytes in vitro
Region
Japan

Condition
Condition None
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Develop a method for in vitro differentiation of memory lymphocytes from naive lymphocytes collected from healthy adults
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Two weeks after the start of naive lymphocyte culture, the number of living cells, differentiation markers expressed on the surface of living cells, size of living cells, and morphology of living cells are evaluated.
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Maneuver
Interventions/Control_1 Collect 20 ml of blood from a healty adult
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 adult with no obvious fever, no serious acute illness, no previous experience of feeling sick due to blood sampling, no anemia, heart disease, kidney disease, liver disease or blood disease, and who has not been diagnosed with an abnormal immune status in the past.
Key exclusion criteria Persons with difficulty in self-determination such as dementia and consciousness disorder
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Yasuhito
Middle name
Last name Tokumoto
Organization Saitama Medical University
Division name Admission Center
Zip code 350-0495
Address 38 Morohongou, Moroyamamachi, Saitama, Japan
TEL 0492762031
Email tokumoto@saitama-med.ac.jp

Public contact
Name of contact person
1st name Yasuhito
Middle name
Last name Tokumoto
Organization Saitama Medical University
Division name Admission Center
Zip code 350-0495
Address 38 Morohongou, Moroyamamachi, Saitama, Japan
TEL 0492762031
Homepage URL
Email tokumoto@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
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 Saitama Medical University
Address 38 Morohongou, Moroyamamachi, Saitama, Japan
Tel 0492762031
Email tokumoto@saitama-med.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

Other administrative information
Date of disclosure of the study information
2019 Year 10 Month 17 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
2019 Year 10 Month 01 Day
Date of IRB
2019 Year 10 Month 25 Day
Anticipated trial start date
2019 Year 11 Month 01 Day
Last follow-up date
2023 Year 03 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
2019 Year 10 Month 16 Day
Last modified on
2020 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043665

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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