UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008799
Receipt number R000010029
Scientific Title Generation of humanaized mice by using human PBMC and their applications for research
Date of disclosure of the study information 2012/09/15
Last modified on 2024/03/08 09:34:20

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Basic information

Public title

Generation of humanaized mice by using human PBMC and their applications for research

Acronym

Generation of humanaized mice and their applications for research

Scientific Title

Generation of humanaized mice by using human PBMC and their applications for research

Scientific Title:Acronym

Generation of humanaized mice and their applications for research

Region

Japan


Condition

Condition

healthy volunteer

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Generation of humanaized mice by using human PBMC and their applications for research

Basic objectives2

Others

Basic objectives -Others

application research

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Examine immune system of humanaized mice generated by using human PBMC

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

blood sampling

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

healthy volunteer

Key exclusion criteria

1)peroson with impaired mental status
2)person whose Hb is less than 12g/dl.(for 100ml blood sampling)
3)peson who is cinsidered to be impropriety for this study by execution doctors.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Takehara
Middle name
Last name Tetsuo

Organization

Osaka University Graduate School of Medicine

Division name

Gastroenterology and Hepatology

Zip code

5650871

Address

2-2 Yamadaoka Suita Osaka

TEL

0668793621

Email

hikita@gh.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name Hikita
Middle name
Last name Hayato

Organization

Osaka University Graduate School of Medicine

Division name

Gastroenterology and Hepatology

Zip code

5650871

Address

2-2 Yamadaoka Suita Osaka

TEL

06-6879-3621

Homepage URL


Email

hikita@gh.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

AMED

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

Ethics Commission of Osaka University Hospital and the institutional review boards

Address

1-15 Yamadaoka Suita Osaka

Tel

06-6210-8296

Email

rinri@hp-crc.med.osaka-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

2012 Year 09 Month 15 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

2012 Year 09 Month 15 Day

Date of IRB

2012 Year 10 Month 04 Day

Anticipated trial start date

2012 Year 10 Month 04 Day

Last follow-up date

2027 Year 07 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

2012 Year 08 Month 29 Day

Last modified on

2024 Year 03 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010029


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name