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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017969
Receipt No. R000020822
Scientific Title Fabrication And Characterization of Human Mucosal Epithelial Cell Sheets
Date of disclosure of the study information 2015/06/18
Last modified on 2019/08/25

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Basic information
Public title Fabrication And Characterization of Human Mucosal Epithelial Cell Sheets
Acronym Research of Human Mucosal Epithelial Cell Sheets
Scientific Title Fabrication And Characterization of Human Mucosal Epithelial Cell Sheets
Scientific Title:Acronym Research of Human Mucosal Epithelial Cell Sheets
Region
Japan

Condition
Condition nasal, middle ear or pharynx surgical case
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To develop a new method to transplant autologous mucosal epithelial cell sheets into the damaged middle ear cavity.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fabrication And Characterization of Human Mucosal Epithelial Cell Sheets
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria nasal, middle ear or pharynx surgical case (over 20 years old patient)
Key exclusion criteria None
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Tsunetaro
Middle name
Last name Morino
Organization The Jikei University School of Medicine
Division name Otorhinolaryngology
Zip code 105-8461
Address 3-25-8, Nishi-Shinbashi, Minatoku, Tokyo, Japan
TEL 03-3433-1111
Email moritune@jikei.ac.jp

Public contact
Name of contact person
1st name Tsunetaro
Middle name
Last name Morino
Organization The Jikei University School of Medicine
Division name Otorhinolaryngology
Zip code 105-8461
Address 3-25-8, Nishi-Shinbashi, Minatoku, Tokyo, Japan
TEL 03-3433-1111
Homepage URL
Email moritune@jikei.ac.jp

Sponsor
Institute Japan Science and Technology Agency
Institute
Department

Funding Source
Organization The Jikei University School of Medicine
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor tokyo women medical university waseda university joint institution for advanced biomedical sciences
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Jikei University School of Medicine, research ethics committee
Address 3-19-18, Nishishimbashi,Minato-ku,Tokyo
Tel 03-3433-1111
Email rinri@jikei.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
2015 Year 06 Month 18 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 Enrolling by invitation
Date of protocol fixation
2015 Year 03 Month 12 Day
Date of IRB
2015 Year 03 Month 12 Day
Anticipated trial start date
2015 Year 06 Month 18 Day
Last follow-up date
2021 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To examine suitable condition of cell sheet's fabrication using sample.
To evaluate sheet's histological analysis,
and to analyze gene expression.

Management information
Registered date
2015 Year 06 Month 18 Day
Last modified on
2019 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020822

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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