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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006650
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Tokai University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007410

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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