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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033162
Receipt No. R000037822
Scientific Title Analysis of pathology of locomotive disorder and application of synovial mesenchymal stem cells for regenerative medicine
Date of disclosure of the study information 2018/06/29
Last modified on 2019/03/31

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Basic information
Public title Analysis of pathology of locomotive disorder and application of synovial mesenchymal stem cells for regenerative medicine
Acronym Study of synovial mesenchymal stem cells and its application for regenerative medicine
Scientific Title Analysis of pathology of locomotive disorder and application of synovial mesenchymal stem cells for regenerative medicine
Scientific Title:Acronym Study of synovial mesenchymal stem cells and its application for regenerative medicine
Region
Japan

Condition
Condition locomotive disorder
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Transfer of the established technique to the external faculty for efficient proliferation of synovial mesenchymal stem cells under human serum.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Proliferative property of synovial mesenchymal stem cells under volunteers' serum.
Key secondary outcomes

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
Medicine
Interventions/Control_1 Serum is extracted from volunteer's blood, and synovial mesenchymal stem cells are cultured by using 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
70 years-old >=
Gender Male and Female
Key inclusion criteria Healthy adult volunteers with no remarkable medical record and afford to undergo blood sampling as much as 300ml.
Key exclusion criteria Anemic patients
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Ichiro
Middle name
Last name Sekiya
Organization Tokyo Medical and Dental University
Division name Center of Stem Cell and Regenerative Medicine
Zip code 113-8519
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 0358034017
Email sekiya.arm@tmd.ac.jp

Public contact
Name of contact person
1st name Office administrator
Middle name
Last name Office administrator
Organization Tokyo Medical and Dental University
Division name Center of Stem Cell and Regenerative Medicine
Zip code 113-8519
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 0358034017
Homepage URL
Email saisei01.arm@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Japanese Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization IRB for TMDU
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel 0358036111
Email info.bec@tmd.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
2018 Year 06 Month 29 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 Enrolling by invitation
Date of protocol fixation
2018 Year 06 Month 29 Day
Date of IRB
2017 Year 10 Month 31 Day
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 27 Day
Last modified on
2019 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037822

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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