UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031786 |
|---|---|
| Receipt number | R000036275 |
| Scientific Title | Establishment of human iPS cells differentiation from TOF |
| Date of disclosure of the study information | 2018/04/04 |
| Last modified on | 2019/12/19 19:05:31 |
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Basic information
Public title
Establishment of human iPS cells differentiation from TOF
Acronym
Establishment of human iPS cells differentiation from TOF
Scientific Title
Establishment of human iPS cells differentiation from TOF
Scientific Title:Acronym
Establishment of human iPS cells differentiation from TOF
Region
| Japan |
Condition
Condition
tetralogy of fallot
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Fibroblasts are separately cultured from surgical residual specimens during pediatric cardiac surgery, and established to induce human iPS cells using them.
Basic objectives2
Others
Basic objectives -Others
Genome analysis, epigenome analysis, DNA damage analysis, differentiation induction analysis into cardiomyocytes and quality evaluation are performed from the human iPS cells. In addition, we evaluate the linkage between disease and human iPS cell function.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of genome analysis, epigenome analysis, DNA damage and cardiomyocyte differentiation induction analysis and quality assessment using human iPS cells in tetralogy of Fallot and other congenital heart diseases.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Gene |
Interventions/Control_1
Genome analysis, epigenome analysis, DNA damage and cardiomyocyte differentiation induction analysis and quality assessment using human iPS cells in tetralogy of fallot.
Interventions/Control_2
Genome analysis, epigenome analysis, DNA damage and cardiomyocyte differentiation induction analysis and quality assessment using human iPS cells in other congenital heart disease.
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
| 1 | weeks-old | <= |
Age-upper limit
| 864 | weeks-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who undergone pediatric cardiac surgery, and be dissected thymus tissue as a residual specimen, and taken written consent to this study.
Key exclusion criteria
Patients who were unable to take consent to this study in writing.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ryusuke |
| Middle name | |
| Last name | Hosoda |
Organization
Saitama medical university International medical Center
Division name
Pediatric cardiac surgeon
Zip code
350-1298
Address
1397-1, Yamane, Hidaka-City, Saitama-Pref, Japan
TEL
042-984-4111
medicaryu@live.jp
Public contact
Name of contact person
| 1st name | Ryusuke |
| Middle name | |
| Last name | Hosoda |
Organization
Saitama medical university International medical Center
Division name
Pediatric cardiac surgeon
Zip code
350-1298
Address
1397-1, Yamane, Hidaka-City, Saitama-Pref, Japan
TEL
042-984-4111
Homepage URL
medicaryu@live.jp
Sponsor or person
Institute
Saitama medical university International medical Center
Institute
Department
Personal name
Funding Source
Organization
Saitama medical university International medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama medical university International medical Center
Address
1397-1, Yamane, Hidaka-City, Saitama-Pref, Japan
Tel
042-984-4523
chikens@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
| 2018 | Year | 04 | Month | 04 | 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
| 2018 | Year | 04 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2022 | 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
| 2018 | Year | 03 | Month | 19 | Day |
Last modified on
| 2019 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036275
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
