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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000008266 |
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Date of registration:
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01/07/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Transplantation of a scaffold-free tissue engineered construct (TEC) derived from autologous synovial mesenchymal stem cells for cartilage repair
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Scientific title:
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Transplantation of a scaffold-free tissue engineered construct (TEC) derived from autologous synovial mesenchymal stem cells for cartilage repair - Transplantation of a scaffold-free tissue engineered construct (TEC) for cartilage repair |
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Date of first enrolment:
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2012/09/01 |
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Target sample size:
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6 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009672 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Phase II,III
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Countries of recruitment
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Japan
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Contacts
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Name:
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Hideki
Yoshikawa |
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Address:
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2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan
Japan |
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Telephone:
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06-6879-3552 |
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Email:
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yhideki@ort.med.osaka-u.ac.jp |
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Affiliation:
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Osaka University Graduate School of Medicine Department of Orthopaedics |
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Name:
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Norimasa
Nakamura |
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Address:
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2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan
565-0871
Japan |
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Telephone:
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06-6879-3552 |
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Email:
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n-nakamura@ort.med.osaka-u.ac.jp |
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Affiliation:
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Osaka University Center for Advanced Medical Engineering and Infomatics |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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) Patello-femoral instability 7) Diabetes 8) Renal failure which requires dialysis 9) Infectious disease (HIV, HBV, HCV, HTLV, syphilis) 10) Pregnancy 11) the medication of corticosteroids 12) participation in other clinical trials 13)Judged inappropriate with other reason by the project investigators.
Age minimum:
20years-old
Age maximum:
60years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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traumatic chondral injury of the knee joint
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Intervention(s)
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Implantation of a scaffold-free tissue engineered construct (TEC) derived from autologus synovial mesenchymal stem cell (MSC) for cartilage repair.
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Primary Outcome(s)
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<Adverse events> presense or absence, pattern, severity, incidence and retention time of adverse events
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Secondary Outcome(s)
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Periodical assesement of clnical symptoms, evaluatetion by MRI, histology, activity scales (Lyshom, Tegnar), and by overall subjective assessment score (Knee Injury and Osteoarthritis Outcome Score, KOOS). Arthoscopic assessment of repaired tissue using ICRS evaluation package.
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Source(s) of Monetary Support
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Health Labour Sciences Research Grant
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Ethics review
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Status: YES
Approval date: 02/05/2012
Contact:
irb-jimu@hp-mctr.med.osaka-u.ac.jp
Osaka University Clinical Research Review Committee
06-6879-6551
irb-jimu@hp-mctr.med.osaka-u.ac.jp
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