UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016798 |
|---|---|
| Receipt number | 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 14:12:35 |
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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
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
senbont@saitama-med.ac.jp
Sponsor or person
Institute
Department of cardiology
International medical center Saitama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019498
