UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038311 |
|---|---|
| Receipt number | 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 | 2025/04/21 10:40:04 |
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Basic information
Public title
A trial of induced differentiation of human memory 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
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
tokumoto@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
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
0492762143
rinri@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
https://academic.oup.com/cei/article/207/1/95/6431488?login=true
Publication of results
Partially published
Result
URL related to results and publications
https://academic.oup.com/cei/article/207/1/95/6431488?login=true
Number of participants that the trial has enrolled
20
Results
Naive T cells purified from peripheral blood of healthy donors were activated through T cell receptor signaling and appropriate cytokines for several days in culture. All T cell activators were then removed from the medium, and the cultures continued under hypoxic conditions (1% O2) for several more days. Most cells died during this period, but some cells survived in a quiescent state for up to a month.
Results date posted
| 2024 | Year | 07 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 01 | Month | 28 | Day |
Baseline Characteristics
Healthy adult men and women
Participant flow
Public recruitment
Adverse events
None
Outcome measures
Cell culture
Plan to share IPD
None
IPD sharing Plan description
Not applicable
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
| 2027 | 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
| 2025 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043665
