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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042301
Receipt No. R000048289
Scientific Title Clinical Research regarding allogeneic cell bank for regenerative medicine
Date of disclosure of the study information 2020/11/04
Last modified on 2020/10/30

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Basic information
Public title Clinical Research regarding allogeneic cell bank for regenerative medicine
Acronym Clinical Research regarding allogeneic cell bank for regenerative medicine
Scientific Title Clinical Research regarding allogeneic cell bank for regenerative medicine
Scientific Title:Acronym Clinical Research regarding allogeneic cell bank for regenerative medicine
Region
Japan

Condition
Condition wisdom tooth
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify banking of fibroblasts
Basic objectives2 Others
Basic objectives -Others To verify banking of fibroblasts isolated from excised tissues in treatment of wisdom tooth extraction
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To establish 10 fibroblast lines from excised tissues
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
12 years-old <=
Age-upper limit
25 years-old >=
Gender Male and Female
Key inclusion criteria 1. Those who are planning to have tooth extraction after 3 weeks or later from obtaining consent.
2. Research subjects with written consent.
3. When the research subject is a minor, written consent should be obtained from substitute of relation in the second degree.
Key exclusion criteria 1. Patients suffering from and having treatment history of infectious diseases such as treponema pallidum, chlamydia, gonorrhea, mycobacterium tuberculosis.
2. Patients with sepsis and suspected sepsis.
3. Patients with treatment history of malignant tumors.
4. Patients with serious metabolic disorders.
5. Patients with endocrine disorders.
6. Patients with collagen disease.
7. Patients with blood dyscrasia.
8. Patients with liver disease.
9. Patients with transmissible spongiform encephalopathy and suspected. Patients with suspected dementia.
10. Patients with a specific genetic disorder or family history.
11. Patients who have had blood transfusions.
12. Patients who have had a transplant.
13. Patients who are determined to be inappropriate as a research subject.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Kimikazu
Middle name
Last name Hamano
Organization Yamaguchi University
Division name Department of Surgery and Clinical Science, Graduate School of Medicine
Zip code 7558505
Address 1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL 0836-22-2261
Email cres-sg1@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name Koji
Middle name
Last name Ueno
Organization Yamaguchi University
Division name Department of Surgery and Clinical Science, Graduate School of Medicine
Zip code 7558505
Address 1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL 0836-22-2261
Homepage URL
Email cres-sg1@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University
Institute
Department

Funding Source
Organization Yamaguchi University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Yamaguchi University Institutional Review Board
Address 1-1-1 Minami-Kogushi, Ube, Yamaguchi
Tel 0836-22-2428
Email clin_res@yamaguchi-u.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
2020 Year 11 Month 04 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 Preinitiation
Date of protocol fixation
2020 Year 10 Month 06 Day
Date of IRB
2020 Year 10 Month 28 Day
Anticipated trial start date
2020 Year 11 Month 09 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To establish 10 fibroblast lines from excised tissues in the treatment after wisdom tooth extraction.

Management information
Registered date
2020 Year 10 Month 30 Day
Last modified on
2020 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048289

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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