UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012347 |
|---|---|
| Receipt number | R000008607 |
| Scientific Title | Articular cartilage repair with autologous bone marrow mesenchymal cells under arthroscopic surgery |
| Date of disclosure of the study information | 2014/01/01 |
| Last modified on | 2017/05/23 14:34:51 |
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Basic information
Public title
Articular cartilage repair with autologous bone marrow mesenchymal cells under arthroscopic surgery
Acronym
Arcticular cartilage repair with injection of bonemarrow mesenchymal cells
Scientific Title
Articular cartilage repair with autologous bone marrow mesenchymal cells under arthroscopic surgery
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Shigeyuki Wakitani |
Organization
Mukogawa Women's University
Division name
School of Health and Sports Sciences
Zip code
Address
6-46 Ikehiraki-machi, Nishinomiya
TEL
0798-45-9907
wakitani@mukogawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeyuki Wakitani |
Organization
Mukogawa Women's University
Division name
School of Sports and HEalth Sciences
Zip code
Address
6-46 Ikehiraki-machi, Nishinomiya
TEL
0798-45-9907
Homepage URL
swakitani44@gmail.com
Sponsor or person
Institute
Mukogawa Women's University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Terminated
Date of protocol fixation
| 2013 | Year | 10 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008607
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
