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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012040
Receipt No. R000014076
Scientific Title Patient-specific iPS cells for cardiovascular diseases
Date of disclosure of the study information 2013/10/16
Last modified on 2016/04/15

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Basic information
Public title Patient-specific iPS cells for cardiovascular diseases
Acronym iPS cells for cardiovascular diseases
Scientific Title Patient-specific iPS cells for cardiovascular diseases
Scientific Title:Acronym iPS cells for cardiovascular diseases
Region
Japan

Condition
Condition Cardiovascular diseases
Classification by specialty
Cardiology Vascular surgery Pediatrics
Cardiovascular surgery Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Generation of iPS cells by using peripheral blood from patients with cardiovascular diseases
Basic objectives2 Others
Basic objectives -Others Modelling cardiovascular diseases to develop novel cardiac regeneration therapy
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes N/A
Key secondary outcomes N/A

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 Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Peripheral blood sampling
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
0 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria Cardiovascular diseases
Key exclusion criteria N/A
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidemasa Oh
Organization Okayama University Hospital
Division name Center for Innovative Clinical Medicine
Zip code
Address 2-5-1 Shikata-cho Kita-ku Okayama
TEL 086-223-7151
Email hidemasa@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Rie Yokoyama
Organization Okayama University Hospital
Division name Center for Innovative Clinical Medicine
Zip code
Address 2-5-1 Shikata-cho Kita-ku Okayama
TEL 086-235-6504
Homepage URL
Email yokoyama-r@adm.okayama-u.ac.jp

Sponsor
Institute Okayama University Hospital
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 岡山大学病院

Other administrative information
Date of disclosure of the study information
2013 Year 10 Month 16 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 Completed
Date of protocol fixation
2013 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 21 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 05 Month 31 Day
Date analysis concluded
2017 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 10 Month 15 Day
Last modified on
2016 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014076

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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