UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051465 |
|---|---|
| Receipt number | R000058707 |
| Scientific Title | Establishment of isolation and culture methods of primary human osteocytes/osteocytes from the ilium. |
| Date of disclosure of the study information | 2023/06/28 |
| Last modified on | 2023/06/28 16:03:07 |
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Basic information
Public title
Establishment of Isolate bone cells from human ilium
Acronym
Establishment of Isolate bone cells from human ilium
Scientific Title
Establishment of isolation and culture methods of primary human osteocytes/osteocytes from the ilium.
Scientific Title:Acronym
Establishment of isolation and culture methods of primary human osteoblasts/osteocytes from the ilium.
Region
| Japan |
Condition
Condition
Patients undergoing iliac bone transplantation for oral surgery (cleft palate/lip, tumor, jaw deformity)
Classification by specialty
| Oral surgery | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The applicants establish a technology to isolate and culture human primary cells from fresh iliac bone and bone marrow tissue left over from bone transplantation and use them to treat various diseases. It is intended to be useful in the development of bone biology or elucidating pathologies and establishing treatment methods.
Basic objectives2
Others
Basic objectives -Others
Establishment of experimental methods
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
transcription level, protein expression level
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 5 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with non-syndromic diseases of the jaw/oral cavity
Key exclusion criteria
Patients with syndromic diseases of the jaw/oral cavity
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Kazuaki |
| Middle name | |
| Last name | Miyagawa |
Organization
Osaka University
Division name
Graduate School of Dentistry
Zip code
5650871
Address
1-8 Yamadaoka, Suita, Japan
TEL
+81-6-6879-2936
miyagawa.kazuaki.dent@osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuaki |
| Middle name | |
| Last name | Miyagawa |
Organization
Osaka University
Division name
Graduate School of Dentistry
Zip code
5650871
Address
1-8 Yamadaoka, Suita, Japan
TEL
+81-6-6879-2936
Homepage URL
miyagawa.kazuaki.dent@osaka-u.ac.jp
Sponsor or person
Institute
Osaka University, Graduate School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The institutional review board and ethics committee of Osaka University Dental Hospital
Address
1-8, Yamada-oka, Suita, Japan
Tel
0668795111
si-soumu-syomu@office.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
| 2023 | Year | 06 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The institutional review board and ethics committee of Osaka University Dental Hospital(#R2-E34)
Management information
Registered date
| 2023 | Year | 06 | Month | 28 | Day |
Last modified on
| 2023 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058707
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
