UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033162 |
|---|---|
| Receipt number | 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 22:46:34 |
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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
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
saisei01.arm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037822
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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