UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Synovial stem cell transplantation for participants who deviate from clinical trial
Title of the study (Brief title)	Synovial stem cell transplantation for participants who deviate from clinical trial
Region	Japan

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

Objectives
Narrative objectives1	To investigate the safety of autologous synovial stem cell transplantation after meniscus repair
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Adverse event including type, frequency, severity and duration
Key secondary outcomes	1) Safety Device-related adverse event data,including type, frequency,severity and duration 2) Efficacy Lysholm score,Knee Injury and Osteoarthritis Outcome Score (KOOS),Numerical Rating Scale (NRS)

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 after meniscus repair
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 participated in clinical trial of autologous synovial stem cell transplantation after meniscus repair 2) Patients who were eligible for both shipping inspection and confirmation inspection below - Sterility test - Mycoplasma negative test - Endotoxin test - Packaging/Display 3) Patients for whom transplantation of autologous synovial stem cell products could not be carried out due to nonconformity for following inspections - CFU evaluation - Cell number, viable cell ratio - Cell purity evaluation
Key exclusion criteria	1) Patients with active infection 2) Patient with poor controlled diabetes 3) Patients with complications as shown below and poor general condition. - Severe cardiovascular disease - Severe liver disease - Severe renal dysfunction - Poor mental illness with poor control 4) Pregnant women, lactating women and patient who may be pregnant, or patient who desires pregnancy during clinical study 5) Patient for whom doctors decide as not appropriate to participate in the clinical study
Target sample size	2

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	03-5803-4017
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	http://www.tmd.ac.jp/medhospital/topics/
Email	tiken.crc@tmd.ac.jp

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

Funding Source
Organization	Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization	Self funding
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	2018 Year 01 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 18 Day
Anticipated trial start date	2018 Year 01 Month 16 Day
Last follow-up date
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	2018 Year 01 Month 05 Day
Last modified on	2019 Year 01 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034215