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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031786
Receipt No. R000036275
Scientific Title Establishment of human iPS cells differentiation from TOF
Date of disclosure of the study information 2018/04/04
Last modified on 2018/03/19

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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

Not applicable
Age-upper limit

Not applicable
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
Middle name
Last name Ryusuke Hosoda
Organization Saitama medical university International medical Center
Division name Pediatric cardiac surgeon
Zip code
Address 1397-1, Yamane, Hidaka-City, Saitama-Pref, Japan
TEL 042-984-4111
Email medicaryu@live.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryusuke Hosoda
Organization Saitama medical university International medical Center
Division name Pediatric cardiac surgeon
Zip code
Address 1397-1, Yamane, Hidaka-City, Saitama-Pref, Japan
TEL 042-984-4111
Homepage URL
Email medicaryu@live.jp

Sponsor
Institute Saitama medical university International medical Center
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2018 Year 04 Month 04 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 04 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
2018 Year 03 Month 19 Day
Last modified on
2018 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036275

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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