UMIN-CTR Clinical Trial

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
Email	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
Email	ozeki.arm@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045063