UMIN-CTR Clinical Trial

Basic information
Public title	Investigator initiated clinical trial of autologous synovial stem cells for meniscus lesions
Acronym	Autologous synovial MSCs for meniscus lesions
Scientific Title	Investigator initiated clinical trial of autologous synovial stem cells for meniscus lesions
Scientific Title:Acronym	Autologous synovial MSCs for meniscus lesions
Region	Japan

Condition
Condition	meniscus lesions
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy and safety of autologous synovial stem cells transplanted on the meniscal lesions.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Lysholm score
Key secondary outcomes	1) Efficacy Knee Injury and Osteoarthritis Outcome Score (KOOS) Numerical Rating Scale (NRS) Knee X-ray examination, MRI 3D analysis (meniscal thickness, height, width) MRI analysis of meniscal / cartilage degeneration 2) Safety Adverse event and device-related adverse event data, including type, frequency, severity and duration

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 Other
Interventions/Control_1	Transplantation of autologous synovial stem cells on the meniscal lesions.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients who are aged 20 years or older on the acquisition date of informed consent before clinical study, and who can give a written informed consent 2) Patients with meniscus injuries including radial, vertical flap, horizontal flap, horizontal, degenerative or complex tear and patients with meniscus injuries located in the avascular area 3) Patients with clinical symptoms of meniscus injury, including pain 4) Patients with one or more of the following symptoms in the knee: -catching sensation -instability feeling -limited range of motion -hydrarthrosis 5) Patients who are indicated for menisectomy of 100 mm2 or larger because of (2) to (4)
Key exclusion criteria	1) Patient who is unidentified 2) Patients who underwent menisectomy or meniscus repair in the affected knee 3) Patients whose clinical symptoms have been sufficiently improved by conservative treatments in the last 3 months 4) Patients with knee malalignment. 5) Patients with a history of trauma in the knee 6) Patients for whom MRI is not indicated because of claustrophobia and so on 7) Patients who have had any intraarticular injections (local anesthetic agent, corticosteroid agent, hyaluronic acid) or arthrocentesis in these 3 months. 8) Patients with active infection 9) Patients diagnosed or suspected as malignant tumor in these 5 years 10) Patients sensitive to antibiotics (penicillin, streptomycin or amphotericin B) 11) Patients sensitive to animal (bovine) origin materials 12) Patients with poor controlled diabetes 13) Patients with a pacemaker 14) Patients with poor general condition with following complication; -severe cardiovascular disease -severe liver disorder -severe kidney dysfunction -poorly controlled psychiatric disorder -other diseases which sudden deterioration or aggravation is foreseeable during the study period 15) Pregnant women, lactating women and patient who may be pregnant, or patient who desires pregnancy during clinical study 16) Patient who participated in other clinical trials, patient participating in other clinical studies and patient planning to participate in other clinical studies while participating in this clinical study within 12 weeks before the start of transplantation of cellular product 17) Patient for whom doctors decide as not appropriate to participate in the clinical study
Target sample size	10

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 for Stem Cell and Regenerative Medicine
Zip code	113-8510
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-4017
Email	sekiya.arm@tmd.ac.jp

Public contact
Name of contact person	1st name Office Middle name Last name Administrator
Organization	Tokyo Medical and Dental University, Medical Hospital
Division name	Clinical Research Center
Zip code	113-8510
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5612
Homepage URL	http://www.tmd.ac.jp/medhospital/topics/
Email	tiken.crc@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University, Medical Hospital
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	Tokyo Medical and Dental University Hospital of Medicine, Institutional Review Board
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel	03-5803-5612
Email	tiken.crc@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	東京医科歯科大学医学部附属病院（東京都）

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 01 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	Delay expected
Results Delay Reason	in preparation for submission
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	2017 Year 02 Month 01 Day
Date of IRB	2017 Year 02 Month 27 Day
Anticipated trial start date	2017 Year 07 Month 29 Day
Last follow-up date	2019 Year 02 Month 21 Day
Date of closure to data entry	2019 Year 04 Month 28 Day
Date trial data considered complete	2019 Year 05 Month 10 Day
Date analysis concluded	2019 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 03 Month 03 Day
Last modified on	2020 Year 03 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030110