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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001195
Receipt No. R000000960
Scientific Title Joint repair using an in vitro generated scaffold-free tissue engineerd construct (TEC) derived from autologous synovial mesenchymal stem cells
Date of disclosure of the study information 2008/07/01
Last modified on 2012/06/18

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Basic information
Public title Joint repair using an in vitro generated scaffold-free tissue engineerd construct (TEC) derived from autologous synovial mesenchymal stem cells
Acronym Joint repair by tissue engineerd construct (TEC)
Scientific Title Joint repair using an in vitro generated scaffold-free tissue engineerd construct (TEC) derived from autologous synovial mesenchymal stem cells
Scientific Title:Acronym Joint repair by tissue engineerd construct (TEC)
Region
Japan

Condition
Condition Chondral lesions
Meniscal lesions
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective is to evaluate the feasibility ofin vitro generated mesenchymal stem cell (MSC)-based tissue engineered construct (TEC) to intra-articular lesions.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes Adverse events (National Cancer Institute-Common Toxicity; NCI-CTC; version 2, JACOG version)
Arthoscopic assessment of repaired tissue using ICRS evaluation package (http://www.cartilage.org) for chondral lesions and Horibe score (J Bone Joint Surg Br. 1995; 77:245-9) for meniscal lesions.
Key secondary outcomes Periodical assessment of clinical symptoms, evaluation by MRI, histology, activity scales (Lyshlom, Tegnar), and by overall subjective assessment score (Knee Injury and Osteoarthritis Outcome Score; KOOS)

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 Maneuver
Interventions/Control_1 Implantation of in vitro generated mesenchymal stem cell (MSC)-based tissue engineered construct (TEC) to chondral or meniscal lesions of the knee.
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
15 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria Patients with a symptomatic (including pain, catching, locking, or joint effusion) chondral or meniscal lesion of the knee which is clinically detectable by MRI
Key exclusion criteria Patients with
1) Active local infection
2) Serious complications including malignancies
3) Alchol or drung abuse
4) Rheumatoid arthritis, gout, or pseudo gout
5) Abnormal alignment of lower extremity
6) Chondral lesion with more than 5cm2
7) Meniscal lesion with large defect more than one-third of whole meniscal body
8) Patello-femoral instability
9) Diabetes
10) Renal failure which requires dialysis
11) the medication which could affect chondral metabolosm such as vitamin C or hyaluronan
12) Infectious disease (HIV, HBV, HCV, HTLV, syphilis)
13) Pregnancy
14) Allergy
15) participation in other clinical trials
16)Judged inappropriate with other reason by the project investigators

Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Yoshikawa
Organization Osaka University Graduate School of Medicine
Division name Department of orthopaedics
Zip code
Address 2-2, yamada-oka, Suita, Osaka, 565-0871, Japan
TEL 06-6879-3552
Email

Public contact
Name of contact person
1st name
Middle name
Last name Norimasa Nakamura
Organization Osaka University
Division name Center for Advanced Medical Engineering and Informatics
Zip code
Address 2-2, yamada-oka, Suita, Osaka, 565-0871, Japan
TEL 06-6879-3552
Homepage URL
Email

Sponsor
Institute Department of orthopaedics, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Osaka University Hospital, Medical center for translational Research
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
2008 Year 07 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
2009 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
2012 Year 02 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 06 Month 17 Day
Last modified on
2012 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000960

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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