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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000002358
Receipt No. R000002891
Scientific Title Pathological analysis of hereditary deafness using iPS cells
Date of disclosure of the study information 2009/08/25
Last modified on 2019/08/28

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Basic information
Public title Pathological analysis of hereditary deafness using iPS cells
Acronym hereditary deafness iPS
Scientific Title Pathological analysis of hereditary deafness using iPS cells
Scientific Title:Acronym hereditary deafness iPS
Region
Japan Asia(except Japan)

Condition
Condition Hereditary deafness
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Generate iPS cells from hereditary deafness patient, and induce them into various types of cell line to examine the phenotype. This is expected to reveal the pathology of hereditary deafness, and help us to develop therapy.
Basic objectives2 Others
Basic objectives -Others Pathology
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Phenotype of cell lines derived from hereditary deafness patients
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 Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 harvest skin sample from patient
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 Deafness patients with confirmed mutations, and normal hearing people as control.
Key exclusion criteria Deafness patients without confirmed mutations.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Shin-ichiro
Middle name
Last name Kitajiri
Organization Kyoto University Graduate School of Medicine
Division name Department of Otolaryngology - Head and Neck Surgery
Zip code 606-8507
Address 54 Shogoin Kawaharacho, Sakyo-ku, Kyoto
TEL 075-751-3346
Email kitajiri@ent.kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Shin-ichiro
Middle name
Last name Kitajiri
Organization Kyoto University Graduate School of Medicine
Division name Department of Otolaryngology - Head and Neck Surgery
Zip code 6068507
Address 54 Shogoin-kawaharacho, Sakyo-ku
TEL 075-751-3346
Homepage URL
Email kitajiri@ent.kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Otolaryngology - Head and Neck Surgery, Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto University Graduate School and Faculty of Medicine Kyoto University Hospital Ethics Committe
Address Yoshidakonoetyo, Sakyo-ku, Kyoto
Tel 075-753-4680
Email ethcom@kuhp.kyoto-u.ac.jp

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
2009 Year 08 Month 25 Day

Related information
URL releasing protocol none
Publication of results Unpublished

Result
URL related to results and publications none
Number of participants that the trial has enrolled
Results
Established iPS cells from BOR syndrome patients and mitochondrial 1555 deafness patients.
Results date posted
2019 Year 08 Month 28 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
BOR syndrome patients and mitochondrial 1555 deafness patients.
Participant flow
Harvest skin and blood from the patients diagnosed by genetic testing 
Adverse events
none
Outcome measures
The undifferentiation and  multipotency
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Suspended
Date of protocol fixation
2009 Year 06 Month 09 Day
Date of IRB
2009 Year 05 Month 08 Day
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2016 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 08 Month 20 Day
Last modified on
2019 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002891

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2018/02/26 iPS患者一覧.xls


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