UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012040 |
|---|---|
| Receipt number | 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 10:03:23 |
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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
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
yokoyama-r@adm.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014076
