UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042301
Receipt number 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 2023/05/08 11:47:18

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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 or person

Institute

Yamaguchi University

Institute

Department

Personal name



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

Open public recruiting

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

2023 Year 05 Month 08 Day



Link to view the page

Value
https://center6.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