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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016798
Receipt No. R000019498
Scientific Title Conversion of human atrial or dermal fibroblasts into iPS cells or cardiomyocytes using a direct reprogramming strategy.
Date of disclosure of the study information 2015/03/14
Last modified on 2015/03/14

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Basic information
Public title Conversion of human atrial or dermal fibroblasts into iPS cells or cardiomyocytes using a direct reprogramming strategy.
Acronym Derivation methods of human iPS cells and cardiomyocytes.
Scientific Title Conversion of human atrial or dermal fibroblasts into iPS cells or cardiomyocytes using a direct reprogramming strategy.
Scientific Title:Acronym Derivation methods of human iPS cells and cardiomyocytes.
Region
Japan

Condition
Condition Mase operation
Classification by specialty
Cardiology Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Establishment of derivation methods into iPS cells or directly reprogrammed cardiomyocytes using the exfoliative trial or dermal tissue by maze operation.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Confirmation of expression level of representative anaplastic cells or cardiomyocytes by quantitative-PCR or western blot analysis.
In case of iPS cells, we try to induce mesoderm induction of iPS cells into the cardiomyocytes.
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 Prevention
Type of intervention
Gene
Interventions/Control_1 The exfoliative trial or dermal tissue after maze operation
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria the patients who is performed by the maze operation.
Key exclusion criteria nothing
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takaaki Senbonmatsu
Organization International medical center Saitama Medical University
Division name Department of cardiology
Zip code
Address 1397-1 Yamane Hidaka Saitama
TEL 042-984-4733
Email senbont@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takaaki Senbonmatsu
Organization International medical center Saitama Medical University
Division name Department of cardiology
Zip code
Address 1397-1 Yamane Hidaka Saitama
TEL 042-984-4733
Homepage URL
Email senbont@saitama-med.ac.jp

Sponsor
Institute Department of cardiology
International medical center Saitama Medical University
Institute
Department

Funding Source
Organization Department of cardiology
International medical center Saitama Medical University
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
2015 Year 03 Month 14 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
2012 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 30 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
2015 Year 03 Month 14 Day
Last modified on
2015 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019498

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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