UMIN-CTR Clinical Trial

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