UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006650 |
|---|---|
| Receipt number | R000007410 |
| Scientific Title | The clinical study for the joint treatment by cell sheet |
| Date of disclosure of the study information | 2011/11/02 |
| Last modified on | 2015/05/07 11:29:32 |
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Basic information
Public title
The clinical study for the joint treatment by cell sheet
Acronym
The clinical study for the joint treatment by cell sheet
Scientific Title
The clinical study for the joint treatment by cell sheet
Scientific Title:Acronym
The clinical study for the joint treatment by cell sheet
Region
| Japan |
Condition
Condition
Traumatic and/or degenerative cartilage defect of the Knee joint
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Chondrocyte sheets are fabricated using temperature-responsive culture dish, and to be transplanted to the cartilage defect of the knee joint. We provide objective evaluations of the safety of this new treatment as a primary endpoint.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency and content of adverse events.
Key secondary outcomes
Clinical evaluation, X-ray, MRI, Arthroscopy, Photoacoustic evaluation, and Pathological evaluation.
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
| Device,equipment |
Interventions/Control_1
We confirm the status of cartilage defect and obtain the tissue of cartilage and synovium under arthroscopic technique. Chondrocyte sheets are fabricated using temperature responsive culture dish and to be transplanted to the study patient.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Selection criteria of cartilage defect under arthroscopy is greater than or equal to Outerbridge classification Grade III, and less than 4.2 square centimeter.
Key exclusion criteria
1. Involving ethical, legal and other problems on patient and family.
2. Having severe complications.
3. Having infectious disease (including positive of HBV, HCV, HIV, HTLV, FTA-ABS.)
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Sato |
Organization
Tokai University School of Medicine
Division name
Surgical Science , Department of Orthopaedic Surgery
Zip code
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokai University School of Medicine
Division name
Surgical Science , Department of Orthopaedic Surgery
Zip code
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
Homepage URL
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 02 | 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
Completed
Date of protocol fixation
| 2011 | Year | 02 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 02 | Day |
Last modified on
| 2015 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007410
