UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061774 |
|---|---|
| Receipt number | R000070681 |
| Scientific Title | The Effects of Local Anesthetics on the Proliferation and Multipotency of Synovial Stem Cells |
| Date of disclosure of the study information | 2026/06/02 |
| Last modified on | 2026/06/02 20:25:00 |
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Basic information
Public title
The Effects of Local Anesthetics on the Proliferation and Multipotency of Synovial Stem Cells
Acronym
Effects of Local Anesthetics on Synovial Mesenchymal Stem Cells
Scientific Title
The Effects of Local Anesthetics on the Proliferation and Multipotency of Synovial Stem Cells
Scientific Title:Acronym
Effects of Local Anesthetics on Synovial Mesenchymal Stem Cells
Region
| Japan |
Condition
Condition
Knee Osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate the effects of local anesthetics on the proliferation and differentiation of synovial-derived stem cells isolated and cultured from synovial tissue obtained from the knee, which is scheduled for surgical resection.
Basic objectives2
Others
Basic objectives -Others
Characterization of Synovial Stem Cells
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cartilage Differentiation Assay
Key secondary outcomes
Live cell percentage after enzymatic treatment
Cell yield and viability after approximately two weeks of culture
Adipogenic potential
Bone differentiation potential
Surface antigen expression
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Administer a local anesthetic to the site prior to synovial fluid aspiration
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Knee Osteoarthritis
Key exclusion criteria
Individuals suspected of having an infection.
Individuals deemed medically unsuitable for other reasons.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Sekiya |
Organization
Institute of Science Tokyo
Division name
Center for Stem Cell and Regenerative Medicine
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8510, Japan
TEL
03-5803-4017
sekiya.arm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | administrator |
| Middle name | |
| Last name | Office |
Organization
Institute of Science Tokyo
Division name
Center for Stem Cell and Regenerative Medicine
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8510, Japan
TEL
03-5803-4017
Homepage URL
saisei01.arm@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Ethics Committee of Institute of Science Tokyo
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8510, Japan
Tel
03-5803-4547
rinri.adm@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
| 2026 | Year | 06 | Month | 02 | 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
| 2026 | Year | 06 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 06 | Month | 02 | Day |
Last modified on
| 2026 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070681
