UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015345
Receipt number R000017851
Scientific Title Induced pluripotent stem cell (iPSC)-derived immortalized megakaryocyte cell lines (imMKCLs) from voluntary blood component donors with specific HLA haplotypes towards platelet products in transfusion therapy.
Date of disclosure of the study information 2014/11/01
Last modified on 2022/10/12 09:29:42

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Basic information

Public title

Induced pluripotent stem cell (iPSC)-derived immortalized megakaryocyte cell lines (imMKCLs) from voluntary blood component donors with specific HLA haplotypes towards platelet products in transfusion therapy.

Acronym

Generation of transfusible platelets with specific HLA haplotypes from human iPSC-derived megakaryocyte cell lines

Scientific Title

Induced pluripotent stem cell (iPSC)-derived immortalized megakaryocyte cell lines (imMKCLs) from voluntary blood component donors with specific HLA haplotypes towards platelet products in transfusion therapy.

Scientific Title:Acronym

Generation of transfusible platelets with specific HLA haplotypes from human iPSC-derived megakaryocyte cell lines

Region

Japan


Condition

Condition

Thrombocytopenia

Classification by specialty

Hematology and clinical oncology Blood transfusion

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

Aim of this study is (1) to establish iPSC-derived immortalized megakaryocyte cell lines from blood component donors with specific HLA haplotypes, and (2) to produce platelet product in vitro towards clinical use.

Basic objectives2

Others

Basic objectives -Others

Development of novel technologies towards clinical application by human stem cells

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

In vitro safety and functional studies by platelets generated from human iPSC-derived immortalized megakaryocyte cell lines

Key secondary outcomes



Base

Study type

Observational


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

・Voluntary, non-remunerated, healthy blood component donors
・Homozygotes of HLA-A, HLA-B, and HLA-C
・Blood type O
・Individuals capable of giving voluntary, informed consent in writing

Key exclusion criteria

・The following viral infection:
Hepatic Virus B
Hepatic Virus C
Human Immunodeficiency Virus
Human T-cell leukemia virus
Human parvovirus B19
Cytomegalovirus
・The following microbial infection:
Treponema pallidum
West Nile Virus
Chlamydiaceae
Genus Neisseria
Mycobacterium
Malaria parasites(Plasmodium spp.)
Babesia
Trypanosoma cruzi
Leishmania
Trypanosoma brucei
・Malignant neoplasm
・Transmissible spongiform encephalopathy (including suspected case), Dementia or cognitive impairment, Stroke, Seizure
・The following conditions:
Particular or genetic/hereditary disorders
Severe or uncontrolled metabolic or endocrinal disorders
Connective tissue diseases
Severe or uncontrolled hematologic diseases
Severe or uncontrolled hepatic disorders
・Enrolling related studies of generating iPSC banks

Target sample size

3


Research contact person

Name of lead principal investigator

1st name Koji
Middle name
Last name Eto

Organization

Center for iPS Cell Research and Application (CiRA), Kyoto University

Division name

Department of Clinical Application

Zip code

606-8507

Address

53 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan

TEL

075-366-7075

Email

kojieto@cira.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Koji
Middle name
Last name Eto

Organization

Center for iPS Cell Research and Application (CiRA), Kyoto University

Division name

Department of Clinical Application

Zip code

606-8507

Address

53 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan

TEL

075-366-7075

Homepage URL


Email

kojieto@cira.kyoto-u.ac.jp


Sponsor or person

Institute

・Center for iPS Cell Research and Application (CiRA), Kyoto University
・Kyoto University Hospital

Institute

Department

Personal name



Funding Source

Organization

Japan Science and Technology Agency (JST)

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Bioethics Committee of Kyoto University Graduate School of Medicine, Faculty of Medicine, and Kyoto University Hospital

Address

Konoe-cho, Yoshida, Sakyo-ku, Kyoto, Kyoto

Tel

075-753-4680

Email

ethcom@kuhp.kyoto-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

京都大学医学部附属病院(Kyoto University Hospital)


Other administrative information

Date of disclosure of the study information

2014 Year 11 Month 01 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

2014 Year 09 Month 30 Day

Date of IRB


Anticipated trial start date

2014 Year 12 Month 01 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Study of technological development for generating transfusible platelets from human iPSC-derived megakaryocyte cell lines


Management information

Registered date

2014 Year 10 Month 06 Day

Last modified on

2022 Year 10 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017851


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name