UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Articular cartilage repair with autologous bone marrow mesenchymal cells under arthroscopic surgery
Title of the study (Brief title)	Arcticular cartilage repair with injection of bonemarrow mesenchymal cells
Region	Japan

Condition
Condition	articular cartilage injury
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the safty and effectiveness of intra-articular injection of bone marrow mesenchymal cells for articular catilage repair
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	improvement of clinical symptoms
Key secondary outcomes	MRI

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	injection of bone marrow mesenchymal cells into joint
Interventions/Control_2	no cells
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	16 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	1) patients who are planning to receive bone marrow stimulation for articular cartilage defect 2) patients with more than 50% defects of articular cartilage (International Cartilage Repair Society articular cartilage injury classification grade 3 or 4 recognized by MRI) 3) patients with articular cartilage defect lager than 2cm2 recognized by MRI 4) patients with his or her consent by documents
Key exclusion criteria	1) patients who underwent ACL and/or PCL reconstruction within 2 months 2) patients with active cancer 3) pregnant or possively pregnant patients, patients giving the breast to a child or expecting a child during the study periods 4) patients with infections (positive for anti-HIV antibody, HBs antigen, anti-HCV antibody or anti HTLV antibody 5) patients with a psychopathy 6) patients whom the researcher judged to be inappropriate to be enrolled in this study
Target sample size	80

Research contact person
Name of lead principal investigator	Shigeyuki Wakitani
Organization	Mukogawa Women's University
Division name	School of Health and Sports Sciences
Address	6-46 Ikehiraki-machi, Nishinomiya
TEL	0798-45-9907
Email	wakitani@mukogawa-u.ac.jp

Public contact
Name of contact person	Shigeyuki Wakitani
Organization	Mukogawa Women's University
Division name	School of Sports and HEalth Sciences
Address	6-46 Ikehiraki-machi, Nishinomiya
TEL	0798-45-9907
Homepage URL
Email	swakitani44@gmail.com

Sponsor
Institute	Mukogawa Women's University
Institute
Department

Funding Source
Organization	grants-in-Aid from MHLW
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Osaka Univseristy, Hiroshima University, Osaka City Univeristy, Hyogo Medical University, Nara Medical University, Tomishiro Chuo Hospital
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	広島大学、大阪市立大学、兵庫医科大学、奈良医科大学、近畿大学、豊見城中央病院

Other administrative information
Date of disclosure of the study information	2014 Year 01 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 10 Month 01 Day
Anticipated trial start date	2014 Year 10 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	2013 Year 11 Month 19 Day
Last modified on	2017 Year 05 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008607