UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049391 |
|---|---|
| Receipt number | R000056240 |
| Scientific Title | Establishment of a high efficient preparation method of dedifferentiated fat (DFAT) cells using healthy volunteers |
| Date of disclosure of the study information | 2022/11/01 |
| Last modified on | 2022/11/01 16:27:27 |
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Basic information
Public title
Establishment of a high efficient preparation method of dedifferentiated fat (DFAT) cells using healthy volunteers
Acronym
Establishment of a high efficient preparation method of DFAT cells
Scientific Title
Establishment of a high efficient preparation method of dedifferentiated fat (DFAT) cells using healthy volunteers
Scientific Title:Acronym
Establishment of a high efficient preparation method of DFAT cells
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test and manufacture DFAT cells from human subcutaneous adipose tissue to determine the specifications of the final product for clinical trials and to confirm that a stable quality final product can be reproducibly manufactured.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Determination of specifications of DFAT cell final products for clinical trials
Key secondary outcomes
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
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Collection of subcutaneous adipose tissue (5-7 mL)
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
Persons who, after receiving a full explanation of their participation in this study and with full understanding, have given written consent of their own free will to participate in the study.
Key exclusion criteria
Persons deemed inappropriate as research subjects by the principal inveastigator
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Taro |
| Middle name | |
| Last name | Matsumoto |
Organization
Nihon University School of Medicine
Division name
Department of Functional Morphology, Division of Cell Regeneration and Transplantation
Zip code
173-8610
Address
30-1, Ohyaguchi Kami-cho, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
matsumoto.taro@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Taro |
| Middle name | |
| Last name | Matsumoto |
Organization
Nihon University School of Medicine
Division name
Department of Functional Morphology, Division of Cell Regeneration and Transplantation
Zip code
173-8610
Address
30-1, Ohyaguchi Kami-cho, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
Homepage URL
matsumoto.taro@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Itabashi Hospital, Clinical Research Judging Committee
Address
30-1, Ohyaguchi Kami-cho, Itabashi-ku, Tokyo, Japan
Tel
03-3971-8111
med.rinsyokenkyu@nihon-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
日本大学医学部附属板橋病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 01 | 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
| 2022 | Year | 11 | Month | 01 | Day |
Last modified on
| 2022 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056240
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
