UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017969 |
|---|---|
| Receipt number | 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 20:56:27 |
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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
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
moritune@jikei.ac.jp
Sponsor or person
Institute
Japan Science and Technology Agency
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020822
