UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040215 |
|---|---|
| Receipt number | R000045869 |
| Scientific Title | Quality evaluation of cultured cartilage made of isolated chondrocytes from damaged cartilage |
| Date of disclosure of the study information | 2020/04/22 |
| Last modified on | 2024/02/13 12:27:17 |
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Basic information
Public title
Quality evaluation of cultured cartilage made of isolated chondrocytes from damaged cartilage
Acronym
Quality evaluation of cultured cartilage made of isolated chondrocytes from damaged cartilage
Scientific Title
Quality evaluation of cultured cartilage made of isolated chondrocytes from damaged cartilage
Scientific Title:Acronym
Quality evaluation of cultured cartilage made of isolated chondrocytes from damaged cartilage
Region
| Japan |
Condition
Condition
Traumatic cartilage defect of the knee, Osteochondritis dissecans of the knee
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify whether cultured cartilage made of isolated chondrocytes from damaged cartilage is equivalent to that from the unloaded healthy cartilage.
Basic objectives2
Others
Basic objectives -Others
Biological analysis of residual cartilage
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
ECM production ability of the prepared cultured cartilage
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with traumatic cartilage damage or osteochondritis dissecans in the knee joint (defect area of 4 cm^2 or more) undergoing cultured cartilage transplantation
Key exclusion criteria
1) Under 15 years of age
2) Cartilage around the defect could not be collected
3) Infectious diseases (HIV, HBs, HCV, TP, HTLV-1) positive
or untested
4) Infomed consent not obtained
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Takahisa |
| Middle name | |
| Last name | Sasho |
Organization
Chiba University
Division name
Center for Preventive Medical Sciences
Zip code
260-0856
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-290-3896
sasho@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Ryuichiro |
| Middle name | |
| Last name | Akagi |
Organization
Oyumino Central Hospital
Division name
Department of Orthopaedic Surgery
Zip code
266-0033
Address
6-49-9 Oyuminonami, Midori-ku, Chiba City, Chiba Prefecture
TEL
043-300-3355
Homepage URL
ryuichiro.akagi@juneikai.or.jp
Sponsor or person
Institute
Chiba University
Center for Preventive Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Japan Tissue Engineering Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japan Tissue Engineering Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hospital
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
Tel
043-222-7171
chibacrc@mac.com
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
| 2020 | Year | 04 | Month | 22 | 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
15
Results
Some remnant cartilage were negative in Safranin O staining and had advanced fibrosis. Compared to normal chondrocytes, they had gene expression patterns similar to those of dedifferentiated chondrocytes from OA patients. Cultured cartilage prepared from them tended to have a low cartilage matrix production ability. They showed gene expression patterns similar to that of ossified chondrocytes. These data indicated that their quality as raw materials for cultured cartilage was low.
Results date posted
| 2024 | Year | 02 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with traumatic cartilage damage or osteochondritis dissecans in the knee joint (defect area of 4 cm^2 or more) undergoing cultured cartilage transplantation
Key inclusion criteria
1) Under 15 years of age
2) Cartilage around the defect could not be collected
3) Infectious diseases (HIV, HBs, HCV, TP, HTLV-1) positive or untested
4) Infomed consent not obtained
Participant flow
Adverse events
No adverse events
Outcome measures
Characteristics of remnant cartilage that was dissected and discarded to prepare for the transplant sites of cultured cartilage of knee joints.
1. Analysis of cartilage tissue
Total tissue weight, weight of cartilage tissue, number of collected cells, cell density
Histological analysis of tissue sections (HE staining, Safranin O staining)
Gene expression analysis
2. Analysis of prepared cultured-cartilage
Total weight of cultured cartilage, number of collected cells, cell density, proliferation rate
Cartilage matrix production amount
Gene expression analysis
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 12 | Month | 28 | Day |
Other
Other related information
The purpose of this study is to clarify whether cultured cartilage made of isolated chondrocytes from damaged cartilage is equivalent to that from the unloaded healthy cartilage.
Management information
Registered date
| 2020 | Year | 04 | Month | 22 | Day |
Last modified on
| 2024 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045869
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