UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027905 |
|---|---|
| Receipt number | R000031971 |
| Scientific Title | Establishment of human dedifferentiated fat (DFAT) cells preparation method and DFAT cell-based therapies |
| Date of disclosure of the study information | 2017/06/23 |
| Last modified on | 2019/05/28 19:45:53 |
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Basic information
Public title
Establishment of human dedifferentiated fat (DFAT) cells preparation method and DFAT cell-based therapies
Acronym
Generation of dedifferentiated fat (DFAT) cells from lipoaspirate
Scientific Title
Establishment of human dedifferentiated fat (DFAT) cells preparation method and DFAT cell-based therapies
Scientific Title:Acronym
Generation of dedifferentiated fat (DFAT) cells from lipoaspirate
Region
| Japan |
Condition
Condition
Normal healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to establish preparation methods and quality control system of clinical-grade dedifferentiated fat (DFAT) cells using approximately 10 ml of lipoaspirate collected from healthy volunteers. Phenotypic and functional properties of the DFAT cells are examined and compered to those of adipose-derived stem cells (ASCs). Therapeutic potential and transplantation safety of DFAT cells are assessed by animal experiments. Basic research such as the mechanism of adipocyte dedifferentiation is also carried out.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Preparation of the good manufacturing practice-compliant production of DFAT cells
Key secondary outcomes
Therapeutic potential and transplantation safety of DFAT cells will be assessed by animal experiments
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
| Other |
Interventions/Control_1
After injection of 10-50 ml of local anesthesia solution into periumbilical or femoral regions, approximately 10 ml of lipoaspirate is collected using liposucsion cannula. Then DFAT cells are prepared from the lipoaspirate by ceiling culture.
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Participants will be in good health without severe dysfunction of heart, kidney, lung, hematopoiesis.
(2) Subjects with preliminary laboratory tests results considered adequate.
(3) Individuals who are willing to participate in this study with written informed consent.
(4) Subjects who are judged by investigator to be able to undergo liposuction.
Key exclusion criteria
(1) Positive for the following laboratory test results: serological test for syphilis, HBs antigen, HCV antibody, and HIV antibody.
(2) Current active infection or diagnosed with severe infectious diseases within the last 3 months.
(3) Current use of anticoagulation medications that affect bleeding.
(4) Subjects with history of drug or alcohol dependence.
(5) Current use of systemic steroids or immunosuppressive agents
(6) Pregnant woman, lactating mother, or woman who is suspected pregnancy.
(7) Any other medical reasons judged by the doctor-in-charge.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Taro |
| Middle name | |
| Last name | Matsumoto |
Organization
Nihon University School of Medicine
Division name
Division of Cell Regeneration and Transplantation
Zip code
173-8610
Address
30-1, Ohyaguchikami-cho, Itabashi-ku, Tokyo, Japan
TEL
0339728111
matsumoto.taro@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiko |
| Middle name | |
| Last name | Kazama |
Organization
Nihon University School of Medicine
Division name
Division of Cell Regeneration and Transplantation
Zip code
173-8610
Address
30-1, Ohyaguchikami-cho, Itabashi-ku, Tokyo, Japan
TEL
0339728111
Homepage URL
kazama.tomohiko@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 Center
Address
30-1 Ohyaguchi Kamicho, Itabashi-ku, Tokyo, Japan
Tel
0339728111
sakatani.tsugiko@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
| 2017 | Year | 06 | Month | 23 | 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
| 2017 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 23 | Day |
Last modified on
| 2019 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031971
