UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research on the development of the iPS cell stock derived from voluntary HLA homozygoues donor who have donated bone marrow etc.
Title of the study (Brief title)	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	ShinyaYamanaka
Organization	Center for iPS Cell Research and Application (CiRA), Kyoto University
Division name	Department of Reprogramming Science
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	AyumiMatsunaga
Organization	Center for iPS Cell Research and Application (CiRA), Kyoto University
Division name	Medical Application Promotion Office
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 12 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000018633