UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Enhancement of healing for extruded injured meniscus by transplantation of synovial stem cells after meniscus surgery.
Title of the study (Brief title)	Enhancement of healing for extruded injured meniscus by transplantation of synovial stem cells after meniscus surgery.
Region	Japan

Condition
Condition	Knee meniscal tear
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To improve the clinical results for the extruded injured meniscus, autologous synovial mesenchymalstem cells (MSCs) are transplanted to the knee following meniscus repair with centralization technique. The main purpose of this study is to evaluate the safety of synovial MSCs.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Adverse event data, including type, frequency, severity and duration
Key secondary outcomes	1) Safety of the autologous synovial mesenchymal stem cells 2) Subjective score by KOOS and NRS, Observation of knee, Knee functional evaluation by McMurry test and pivot shift test, Lysholm score 3) MRI examination 4) Knee X-ray examination

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	Arthroscopic transplantation of synovial MSCs after meniscus repair with centralization technique
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) Extruded meniscus injury with radial, horizontal, degenerative tear etc. to which meniscal resection is generally indicated 2) Patients with clinical symptoms such as knee joint unstability, limitation in range of motion, hydrarthrosis and pain 3) Patients suitable for surgery 4) Patients to whom meniscal repair is technically possible 5) Patients older than 20 years on the acquisition date of informed consent before clinical study 6) Patients who gave a written informed consent
Key exclusion criteria	1) Patients who didn't give a written informed consent 2) Patients with active infection 3) Patients positive for HIV (HIV-1, 2 Ag, Ab), HBV (HBs Ag), HCV (HCV Ab), or HTLV-1 (HTLV-1 Ab) 4) Patients with active malignant tumors 5) Patients sensitive to antibiotic 6) Pregnant or breast-feeding women 7) Patients with diabetes 8) Patients in bad general physical condition 9) When doctors decide as not appropriate to participate in the clinical study
Target sample size	10

Research contact person
Name of lead principal investigator	Ichiro Sekiya
Organization	Tokyo Medical and Dental University
Division name	Center for Stem Cell and Regenerative Medicine
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8510, Japan
TEL	03-5803-4977
Email	sekiya.arm@tmd.ac.jp

Public contact
Name of contact person	Office administrator
Organization	Medical Hospital of Tokyo Medical and Dental University
Division name	Clinical Research Center
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan
TEL	03-5803-5612
Homepage URL
Email	tiken.crc@tmd.ac.jp

Sponsor
Institute	Medical Hospital of Tokyo Medical and Dental University
Institute
Department

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)

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	2015 Year 06 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 27 Day
Anticipated trial start date	2015 Year 07 Month 08 Day
Last follow-up date	2016 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 06 Month 12 Day
Last modified on	2016 Year 12 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020728