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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name