UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016026 |
|---|---|
| Receipt number | 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 11:55:27 |
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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
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
ips-promotion@cira.kyoto-u.ac.jp
Sponsor or person
Institute
Center for iPS Cell Research and Application (CiRA), Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018633
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
