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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016026
Receipt No. R000018633
Scientific Title Research on the development of the iPS cell stock derived from voluntary HLA homozygoues donor who have donated bone marrow etc.
Date of disclosure of the study information 2015/01/15
Last modified on 2018/07/06

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Basic information
Public title Research on the development of the iPS cell stock derived from voluntary HLA homozygoues donor who have donated bone marrow etc.
Acronym Development of iPS cell stock from bone marrow transplant donors
Scientific Title Research on the development of the iPS cell stock derived from voluntary HLA homozygoues donor who have donated bone marrow etc.
Scientific Title:Acronym Development of iPS cell stock from bone marrow transplant donors
Region
Japan

Condition
Condition healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The purpose of this study is the development of induced pluripotent stem (iPS) cell stock to be used for regenerative medicine. Donors of the derivatization of iPS cells are healthy HLA homozygous donors, whose HLA haplotypes are frequently found in Japanese population and who have registerd to Japan Bone Marrow Bank and have donated bone marrow etc. After informed concents from donors within inclusion criteria and tissue sourcing, human transplantable-grade iPS cells will be derived and stocked. For human transplantation, another research protocol will be submitted.
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 Charactrization of iPS cells derived from HLA homozyougous donor.
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 1)Voluntary, non-remunerated, healthy donors who have donated bone marrow etc.
2)Individuals capable of giving voluntary, informed consent in writing
Key exclusion criteria 1)Enrolling related studies of generating iPSC banks
2)The following viral infection:
Hepatic Virus B
Hepatic Virus C
Human Immunodeficiency Virus
Human T-cell leukemia virus
Human parvovirus B19
Cytomegalovirus
3)The following microbial infection:
Treponema pallidum
West Nile Virus
Chlamydiaceae
Genus Neisseria
Mycobacterium
Malaria parasites(Plasmodium spp.)
Babesia
Trypanosoma cruzi
Leishmania
Trypanosoma brucei
4)Malignant neoplasm
5)Transmissible spongiform encephalopathy (including suspected case), Dementia or cognitive impairment, Stroke, Seizure
6)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

Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name ShinyaYamanaka
Organization Center for iPS Cell Research and Application (CiRA), Kyoto University
Division name Department of Reprogramming Science
Zip code
Address 53 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL 075-366-7000
Email yamanaka@cira.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name AyumiMatsunaga
Organization Center for iPS Cell Research and Application (CiRA), Kyoto University
Division name Medical Application Promotion Office
Zip code
Address 53 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL 075-366-7008
Homepage URL
Email ips-promotion@cira.kyoto-u.ac.jp

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

Funding Source
Organization Japan Agency for Medical Research and Development (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
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2015 Year 01 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
2014 Year 12 Month 09 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Charactrization of iPS cells derived from HLA homozyougous donor.

Management information
Registered date
2014 Year 12 Month 22 Day
Last modified on
2018 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018633

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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