UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058295 |
|---|---|
| Receipt number | R000066612 |
| Scientific Title | Gene editing of human immune cell-derived iPS cells and production of immune cells |
| Date of disclosure of the study information | 2025/06/26 |
| Last modified on | 2025/06/26 20:03:31 |
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Basic information
Public title
Gene editing of human immune cell-derived iPS cells and production of immune cells
Acronym
Gene editing of human immune cell-derived iPS cells and production of immune cells
Scientific Title
Gene editing of human immune cell-derived iPS cells and production of immune cells
Scientific Title:Acronym
Gene editing of human immune cell-derived iPS cells and production of immune cells
Region
| Japan |
Condition
Condition
Gene editing of human immune cell-derived iPS cells and production of immune cells
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The efficacy of cell product will be evaluated using immune cells from healthy donors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Not applicable
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Blood collection from healthy donors
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
with consent
Key exclusion criteria
Not applicable
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Motohashi |
| Middle name | |
| Last name | Shinichiro |
Organization
Chiba University
Division name
Medical Immunology
Zip code
260-8670
Address
1-8-1 Inohana Chuo-ku Chiba
TEL
043-226-2828
motohashi@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Aoki |
| Middle name | |
| Last name | Takahiro |
Organization
Chiba Univerisy
Division name
Medical Immunology
Zip code
260-8670
Address
1-8-1 Inohana Chuo-ku Chiba
TEL
043-226-2828
Homepage URL
aokitakahiro@chiba-u.jp
Sponsor or person
Institute
RIKEN
Institute
Department
Personal name
Funding Source
Organization
Chiba University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
RIKEN
Name of secondary funder(s)
IRB Contact (For public release)
Organization
RIKEN
Address
2-1 Hirosawa Wako
Tel
050-3500-7242
aokitakahiro@chiba-u.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
| 2025 | Year | 06 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2032 | Year | 07 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 26 | Day |
Last modified on
| 2025 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066612
