UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015205 |
|---|---|
| Receipt number | R000017322 |
| Scientific Title | The clinical study for the joint treatment by allogeneic cell sheet |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2022/03/29 12:13:45 |
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Basic information
Public title
The clinical study for the joint treatment by allogeneic cell sheet
Acronym
The clinical study for the joint treatment by allogeneic cell sheet
Scientific Title
The clinical study for the joint treatment by allogeneic cell sheet
Scientific Title:Acronym
The clinical study for the joint treatment by allogeneic cell sheet
Region
| Japan |
Condition
Condition
Cartilage defects associated with osteoarthritis of the knee
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Chondrocytes isolated from samples obtained at polydactyly surgery are passaged in culture as allogeneic cells and then cryopreserved. From the cryopreserved samples, cells which have been verified for safety and property checked as chondrocyte sheet are cultured and fabricated into an allogeneic chondrocyte sheet. The sheet is then transplanted into patient with cartilage defect of the knee joint, and cartilage regeneration is evaluated. We provide objective evaluations of the safety of this new treatment as a primary endpoint.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency and content of adverse events.
Key secondary outcomes
Clinical evaluation, X-ray, MRl, Arthroscopy, Photoacoustic evaluation, and Pathological evaluation.
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 |
Interventions/Control_1
Chondrocytes isolated from samples obtained at polydactyly surgery are passaged in culture as allogeneic cells and then cryopreserved. From the cryopreserved samples, cells which have been verified for safety and property checked as chondrocyte sheet are cultured and fabricated into an allogeneic chondrocyte sheet. The sheet is then transplanted into patient with cartilage defect of the knee joint.
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
Cartilage defects under arthroscopy must be greater than or equal to Outerbridge classification Grade III. In addition, the patellofemoral joint and/or the condyle of the femur must have a cartilage defect or defects which can be fully covered by allogeneic chondrocyte sheets and which have traditionally been indicated for marrow stimulation techniques or osteochondral autografts.
Key exclusion criteria
1. Obtaining informed consent from the patient is difficult.
2. Having complications hindering surgery under general anesthesia or complications affecting knee surgery.
3. Having problematic infectious disease (including positive of HBV, HCV, HIV, HTLV, FTA-ABS.)
4. Having rheumatoid arthritis or other systemic inflammatory disease.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Sato |
Organization
Tokai University School of Medicine
Division name
Surgical Science, Department of Orthopaedic Surgery
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
sato-m@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Sato |
Organization
Tokai University School of Medicine
Division name
Surgical Science, Department of Orthopaedic Surgery
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
Homepage URL
sato-m@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokai university certified committee for regenerative medicine
Address
143 Shimokasuya, Isehara, Kanagawa, 259-1193 Japan
Tel
0463-93-1121
watanabe@tsc.u-tokai.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
| 2014 | Year | 10 | 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
10
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
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 19 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 19 | Day |
Last modified on
| 2022 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017322
