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

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 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

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

Value
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