UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002358 |
|---|---|
| Receipt number | 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 09:33:13 |
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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
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
kitajiri@ent.kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Otolaryngology - Head and Neck Surgery, Kyoto University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
