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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000027905
Receipt No. 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

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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
Email 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
Email kazama.tomohiko@nihon-u.ac.jp

Sponsor
Institute Nihon University
Institute
Department

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
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031971

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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