UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Patient-specific iPS cells for cardiovascular diseases
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Hidemasa Oh
Organization	Okayama University Hospital
Division name	Center for Innovative Clinical Medicine
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	Rie Yokoyama
Organization	Okayama University Hospital
Division name	Center for Innovative Clinical Medicine
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000014076