UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008958 |
|---|---|
| Receipt number | R000010201 |
| Scientific Title | Development of induced pluripotent stem (iPS) cells from patients with muscular disorders for the study of the pathogenesis of the diseases and development of therapies |
| Date of disclosure of the study information | 2012/09/23 |
| Last modified on | 2018/03/31 15:27:04 |
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Basic information
Public title
Development of induced pluripotent stem (iPS) cells from patients with muscular disorders for the study of the pathogenesis of the diseases and development of therapies
Acronym
iPS cell studies of muscular disorders
Scientific Title
Development of induced pluripotent stem (iPS) cells from patients with muscular disorders for the study of the pathogenesis of the diseases and development of therapies
Scientific Title:Acronym
iPS cell studies of muscular disorders
Region
| Japan |
Condition
Condition
Skeletal muscle disease
Myotonic dystrophy
Muscular dystrophies
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To generate induced pluripotent (iPS) stem cells derived from patients with muscular disorders and to use them to determine molecular mechanisms and to develop novel treatments.
Basic objectives2
Others
Basic objectives -Others
Basic pathomechanistic study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Phenotypes of cell lines derived from muscular disorders
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Either of the following subjects suffering from muscular disorders:
1) Subjects scheduled to undergo surgery or biopsy for medical reasons.
2) Subjects from which cultured cells was harvested with previous biopsy and gave consent for the research use of the biopsied samples.
Key exclusion criteria
None
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanori P. Takahashi |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Neurology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka JAPAN
TEL
06-6879-3571
mtakahas@neurol.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanori P. Takahashi |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Neurology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka JAPAN
TEL
06-6879-3571
Homepage URL
mtakahas@neurol.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
MHLW
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
The National Center of Neurology and Psychiatry
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
大阪大学大学院医学系研究科（大阪府）
国立精神・神経医療研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 23 | 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
| 2011 | Year | 09 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Non-Probability Sample
Management information
Registered date
| 2012 | Year | 09 | Month | 22 | Day |
Last modified on
| 2018 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010201
