UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008266 |
|---|---|
| Receipt number | R000009672 |
| Scientific Title | Transplantation of a scaffold-free tissue engineered construct (TEC) derived from autologous synovial mesenchymal stem cells for cartilage repair |
| Date of disclosure of the study information | 2012/07/01 |
| Last modified on | 2020/07/02 10:44:36 |
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Basic information
Public title
Transplantation of a scaffold-free tissue engineered construct (TEC) derived from autologous synovial mesenchymal stem cells for cartilage repair
Acronym
Transplantation of a scaffold-free tissue engineered construct (TEC) for cartilage repair
Scientific Title
Transplantation of a scaffold-free tissue engineered construct (TEC) derived from autologous synovial mesenchymal stem cells for cartilage repair
Scientific Title:Acronym
Transplantation of a scaffold-free tissue engineered construct (TEC) for cartilage repair
Region
| Japan |
Condition
Condition
traumatic chondral injury of the knee joint
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the safety and the feasibility of a scaffold-free tissue engineered construct (TEC) derived from autologus synovial mesenchymal stem cell (MSC) for cartilage repair.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II,III
Assessment
Primary outcomes
<Adverse events>
presense or absence, pattern, severity, incidence and retention time of adverse events
Key secondary outcomes
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.
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 a scaffold-free tissue engineered construct (TEC) derived from autologus synovial mesenchymal stem cell (MSC) for cartilage repair.
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
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) 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.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Yoshikawa |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Orthopaedics
Zip code
565-0871
Address
2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan
TEL
06-6879-3552
yhideki@ort.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Norimasa |
| Middle name | |
| Last name | Nakamura |
Organization
Osaka University
Division name
Center for Advanced Medical Engineering and Infomatics
Zip code
565-0871
Address
2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan
TEL
06-6879-3552
Homepage URL
n-nakamura@ort.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Orthopaedics, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Health Labour Sciences Research Grant
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
Osaka University Clinical Research Review Committee
Address
2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan
Tel
06-6879-6551
irb-jimu@hp-mctr.med.osaka-u.ac.jp
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
| 2012 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
https://research-er.jp/projects/view/129192
Publication of results
Published
Result
URL related to results and publications
https://journals.sagepub.com/doi/full/10.1177/0363546518781825
Number of participants that the trial has enrolled
5
Results
No adverse events were recorded, and self-assessed clinical scores for pain, symptoms, activities of daily living, sports activity, and quality of life were significantly improved at 24 months after surgery. Secure defect filling was confirmed by second-look arthroscopy and magnetic resonance imaging in all cases. Histology of biopsy specimens indicated repair tissue approaching the composition and structure of hyaline cartilage.
Results date posted
| 2020 | Year | 07 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2018 | Year | 07 | Month | 03 | Day |
Baseline Characteristics
Articular cartilage has limited healing capacity, owing in part to poor vascularity and innervation. Once injured, it cannot be repaired, typically leading to high risk for developing osteoarthritis. Thus, cell-based and/or tissue-engineered approaches have been investigated; however, no approach has yet achieved safety and regenerative repair capacity via a simple implantation procedure.
Participant flow
An observational first-in-human study limited to 5 cases was approved by the Ministry of Health, Labor, and Welfare of Japan and performed at Osaka University Hospital between April 2013 and May 2016. Five patients aged 20 to 60 years were enrolled with isolated full-thickness cartilage defects of the knee (<5 cm2, International Cartilage Regeneration & Joint Preservation Society [ICRS] grade III or IV).
Adverse events
N/A
Outcome measures
1. self-assessed clinical scores: Knee Injury and Osteoarthritis Outcome Score (KOOS, Visual Analogue Scale (VAS))
2. International Cartilage Repair Society (ICRS) morphologic and compositional quality
3. arthroscopy (MRI X-ray image)
4. microscopic analysis of repair specimen
5. Lysholm score, Tegner score
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2012 | Year | 05 | Month | 02 | Day |
Date of IRB
| 2012 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 26 | Day |
Last modified on
| 2020 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009672
| Research Plan | |
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| 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 |
