UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001195 |
|---|---|
| Receipt number | 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 16:51:28 |
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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
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
Sponsor or person
Institute
Department of orthopaedics, Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000960
