UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040906
Receipt number R000046701
Scientific Title Manufacturing and storage of alfa-galactosylceramide-pulsed dendritic cells derived from peripheral blood of healthy volunteers
Date of disclosure of the study information 2020/06/26
Last modified on 2023/06/27 13:20:26

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Basic information

Public title

Manufacturing and storage of alfa-galactosylceramide-pulsed dendritic cells derived from peripheral blood of healthy volunteers

Acronym

Manufacturing and storage of alfa-galactosylceramide-pulsed dendritic cells

Scientific Title

Manufacturing and storage of alfa-galactosylceramide-pulsed dendritic cells derived from peripheral blood of healthy volunteers

Scientific Title:Acronym

Manufacturing and storage of alfa-galactosylceramide-pulsed dendritic cells

Region

Japan


Condition

Condition

Healthy volunteer

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to examin the manufacturing and storage methods of alfa-galactosylceramide (alfa-GalCer) pulsed dendritic cells derived from peripheral blood, and to determine the appropriate expiration date for the cells.

Basic objectives2

Others

Basic objectives -Others

The purpose of this study is to examin the manufacturing and storage methods of alfa-galactosylceramide (alfa-GalCer) pulsed dendritic cells derived from peripheral blood, and to determine the appropriate expiration date for the cells.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Not applicable

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

1) Healthy volunteers with no history of present or past cancer treatment
2) Age:20 year-old and above
3) Weight:Male 45kg and above; Female 40kg and above
4) Hemoglobin Content: 12.0g/dL and above
5) After receiving sufficient explanation on participation in this study, each participant acknowledged s/he had understood the terms and conditions of this study, and signed study participant agreement of his/her own free will.

Key exclusion criteria

1) One who has a heart disease, for which we can not perform apheresis
2) One who is taking or injecting corticosteroids
3) One that the principal investigator determines to be inappropriate as a subject

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Shinichiro
Middle name
Last name Motohashi

Organization

Graduate school of Medicine, Chiba University

Division name

Department of Medical Immunology

Zip code

2608670

Address

1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan

TEL

043-222-7171

Email

motohashi@faculty.chiba-u.jp


Public contact

Name of contact person

1st name Shinichiro
Middle name
Last name Motohashi

Organization

Graduate school of Medicine, Chiba University

Division name

Department of Medical Immunology

Zip code

2608670

Address

1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan

TEL

043-222-7171

Homepage URL


Email

motohashi@faculty.chiba-u.jp


Sponsor or person

Institute

Chiba University

Institute

Department

Personal name



Funding Source

Organization

FUJI SOFT INCORPORATED

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Clinical Research Ethics Committee of the Chiba University Hospital

Address

1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan

Tel

043-222-7171

Email

motohashi@faculty.chiba-u.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

2020 Year 06 Month 26 Day


Related information

URL releasing protocol

not applicable

Publication of results

Unpublished


Result

URL related to results and publications

not applicable

Number of participants that the trial has enrolled

5

Results

We produced alpha-galactosylceramide-pulsed dendritic cells from the peripheral blood of healthy subjects and tentative expiration date was established.

Results date posted

2023 Year 06 Month 27 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

not applicable

Participant flow

not applicable

Adverse events

none

Outcome measures

not applicable

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 06 Month 20 Day

Date of IRB

2019 Year 07 Month 23 Day

Anticipated trial start date

2019 Year 09 Month 01 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete

2023 Year 01 Month 31 Day

Date analysis concluded

2023 Year 03 Month 31 Day


Other

Other related information

stored period of dendritic cells


Management information

Registered date

2020 Year 06 Month 25 Day

Last modified on

2023 Year 06 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046701


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name