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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018987
Receipt No. R000021960
Scientific Title Quality characterization data acquisition and manufacturing process validation with oral mucosal cell sheet cultivation
Date of disclosure of the study information 2015/11/30
Last modified on 2020/09/30

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Basic information
Public title Quality characterization data acquisition and manufacturing process validation with oral mucosal cell sheet cultivation
Acronym Quality characterization data acquisition and manufacturing process validation with oral mucosal cell sheet cultivation
Scientific Title Quality characterization data acquisition and manufacturing process validation with oral mucosal cell sheet cultivation
Scientific Title:Acronym Quality characterization data acquisition and manufacturing process validation with oral mucosal cell sheet cultivation
Region
Japan

Condition
Condition Healthy volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To collect manufacturing validation and quality characterization data through the oral mucosal cell sheet manufacturing process from healthy volunteer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Correlation data between diseminated cell number and quality of the cultivated cell sheet
Key secondary outcomes - Correlation data between overall diameter of oral mucosal tissue acquired and cell number succeed in isolating
- Correlation data between cultivation period and quality of the cultivated cell sheet
- The histological characterization data for oral mucosal cell sheet (various immunostaining)

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 Educational,Counseling,Training
Type of intervention
Maneuver
Interventions/Control_1 Tissue collection from oral mucosa
A dentist is to collect the tissue from the subject.
After applying local anesthetic to tissues peripheral to the collection sites, use a biopsy trephine (punch) to collect tissue with a diameter of 6-8 mm from two sites. Suturing is to be carried out as required to stop bleeding.
Subjects will come three times; 1st time for informed consent, 2nd time for oral cleaning and check for infectious disease, and 3rd time for the managing operation site. Using oral mucosal sample, make a cell sheet and check the quality of it.
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
60 years-old >
Gender Male and Female
Key inclusion criteria Healthy volunteer with written informed consent
Key exclusion criteria 1. hematological complications
2. oral complications
3. fever with suspected infection
4. suggested ineligible from medical interview or screening
5. judged ineligible by doctor
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Chie
Middle name
Last name Sotozono
Organization Kyoto Prefectural University of Medicine
Division name Department of Ophthalmology
Zip code 6028566
Address 465 Kajii-cho, Hirokoji-agaru, Kawaramachi-dori, Kamigyo-ku, Kyoto, Japan
TEL 075-251-5577
Email csotozon@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name Chie
Middle name
Last name Sotozono
Organization Kyoto Prefectural University of Medicine
Division name Department of Ophthalmology
Zip code 6028566
Address 465 Kajii-cho, Hirokoji-agaru, Kawaramachi-dori, Kamigyo-ku, Kyoto, Japan
TEL 075-251-5577
Homepage URL
Email csotozon@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Foundation for Biomedical Research and Innovation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Foundation for Biomedical Research and Innovation
Name of secondary funder(s)

IRB Contact (For public release)
Organization KPUM IRB
Address 465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
Tel 075-251-5337
Email rinri@koto.kpu-m.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 京都府立医科大学病院(京都府)
(公財)先端医療振興財団先端医療センター病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 30 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 Open public recruiting
Date of protocol fixation
2016 Year 03 Month 07 Day
Date of IRB
2016 Year 03 Month 18 Day
Anticipated trial start date
2016 Year 05 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
2022 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 09 Month 11 Day
Last modified on
2020 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021960

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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