UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018987 |
|---|---|
| Receipt number | 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 16:30:55 |
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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
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
csotozon@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021960
