UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049999 |
|---|---|
| Receipt number | R000056948 |
| Scientific Title | Development of fibroblast sheets aiming for the practical application |
| Date of disclosure of the study information | 2023/01/10 |
| Last modified on | 2023/01/10 14:15:24 |
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Basic information
Public title
Development of fibroblast sheets aiming for the practical application
Acronym
Development of fibroblast sheets
Scientific Title
Development of fibroblast sheets aiming for the practical application
Scientific Title:Acronym
Development of fibroblast sheets
Region
| Japan |
Condition
Condition
wisdom tooth
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To perform functional analysis and safety of fibroblasts and fibroblast sheets established in Clinical Research regarding allogeneic cell bank for regenerative medicine (UMIN000042301)
Basic objectives2
Others
Basic objectives -Others
To explain that fibroblasts may be used in future clinical research of allogenic transplantation and confirm whether consent can be obtained from donors who to participate in "Clinical Research regarding allogeneic cell bank for regenerative medicine (UMIN000042301)" if donors participate in this clinical research
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1. To verify whether fibroblast sheets can be manufactured
2. To confirm whether it is useful to transplant fibroblast sheets in nonclinical studies
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Donors over the age of 20 who participated in "Clinical Research regarding allogeneic cell bank for regenerative medicine (UMIN000042301)" and was able to establish fibroblasts
Key exclusion criteria
none
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kimikazu |
| Middle name | |
| Last name | Hamano |
Organization
Yamaguchi University
Division name
Department of Surgery and Clinical Science, Graduate School of Medicine
Zip code
7558505
Address
Minami-kogushi 1-1-1, Ube, Yamaguchi
TEL
0836-22-2261
cres-sg1@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Ueno |
Organization
Yamaguchi University
Division name
Department of Surgery and Clinical Science, Graduate School of Medicine
Zip code
7558505
Address
Minami-kogushi 1-1-1, Ube, Yamaguchi
TEL
0836-22-2261
Homepage URL
cres-sg1@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Central Glass Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamaguchi University Institutional Review Board
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
Tel
0836-22-2428
clin_res@yamaguchi-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 | 01 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This clinical research is going to perform functional analysis of fibroblasts established in "Clinical Research regarding allogeneic cell bank for regenerative medicine (UMIN000042301)" and nonclinical studies for fibroblast sheets.
Management information
Registered date
| 2023 | Year | 01 | Month | 10 | Day |
Last modified on
| 2023 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056948
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
