UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039516 |
|---|---|
| Receipt number | R000045063 |
| Scientific Title | Establishment of ultrasound-guided harvest of synovium for regenerative medicine of cartilage and meniscus using synovial mesenchymal stem cells |
| Date of disclosure of the study information | 2020/02/18 |
| Last modified on | 2021/08/19 10:22:22 |
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Basic information
Public title
Establishment of ultrasound-guided harvest of synovium for regenerative medicine of cartilage and meniscus using synovial mesenchymal stem cells
Acronym
Establishment of ultrasound-guided harvest of synovium
Scientific Title
Establishment of ultrasound-guided harvest of synovium for regenerative medicine of cartilage and meniscus using synovial mesenchymal stem cells
Scientific Title:Acronym
Establishment of ultrasound-guided harvest of synovium
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the safery of ultrasound-guided harvest of synovium in the knee joint.
To investigate the proliferation and differentiation potential of synovial mesenchymal stem cells compared with the stem cells that previously obtained by arthroscopic-guided harvest of synovium
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of safety
1. Neurovascular injury just after the surgery
2. Infection
Evaluation of synovial mesenchymal stem cells
1. Proliferation
2. Differentiation potential
3. Cell surface marker
Adverse event
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Ultrasound-guided harvest of synovium in the knee joint
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Knee osteoarthritis patients who have total knee arthroplasty in our hospital and agree with the research
Key exclusion criteria
Patients who are in bad general condition
Patients who have an infectious disease
Patients who are judged as unappropriate in this research
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Nobutake |
| Middle name | |
| Last name | Ozeki |
Organization
Tokyo Medical and Dental University
Division name
Center for Stem Cell and Regenerative Medicine
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-4017
ozeki.arm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Nobutake |
| Middle name | |
| Last name | Ozeki |
Organization
Tokyo Medical and Dental University
Division name
Center for Stem Cell and Regenerative Medicine
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-4017
Homepage URL
ozeki.arm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan 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
Institutional review board, Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-4017
ozeki.arm@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
| 2020 | Year | 02 | Month | 18 | 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
10
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
Completed
Date of protocol fixation
| 2020 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 17 | Day |
Last modified on
| 2021 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045063
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
