UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000008266
Receipt No. 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 (Ver. 7)

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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
Email 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
Email n-nakamura@ort.med.osaka-u.ac.jp

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

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009672