UMIN-CTR Clinical Trial

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
Email	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
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	Saitama medical university International medical Center
Address	1397-1, Yamane, Hidaka-City, Saitama-Pref, Japan
Tel	042-984-4523
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036275