UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011238 |
|---|---|
| Receipt number | R000013168 |
| Scientific Title | Study of megakaryopoiesis and thrombopoiesis by iPS cells derived from a patient with thrombocytopenia |
| Date of disclosure of the study information | 2013/09/01 |
| Last modified on | 2019/05/10 18:20:48 |
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Basic information
Public title
Study of megakaryopoiesis and thrombopoiesis by iPS cells derived from a patient with thrombocytopenia
Acronym
Platelet generation from patient-derived iPS cells
Scientific Title
Study of megakaryopoiesis and thrombopoiesis by iPS cells derived from a patient with thrombocytopenia
Scientific Title:Acronym
Platelet generation from patient-derived iPS cells
Region
| Japan |
Condition
Condition
Chronic thrombocytopenia with platelet transfusion refractoriness
Classification by specialty
| Hematology and clinical oncology | Blood transfusion |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Aim is to study whether platelet generation is feasible from iPS cells in case of a patient with unresponsiveness post repeated platelet transfusion.
Basic objectives2
Others
Basic objectives -Others
1) iPS cell generation is being planned by using two sources from a patient; peripheral blood and bone marrow adherent cells.
2) These sources will be used for iPS cells and further megakaryocytic cells production.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To examine the feasibility of platelet production and functionality in vitro between healthy- and patient-derived derivatives
Key secondary outcomes
To focus on the in vitro functional parameters
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Bone marrow puncture
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
Chronic thrombocytopenia with platelet transfusion refractoriness
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
Epstein-Barr virus
West Nile Virus
The following bacterial infection:
Treponema pallidum
Chlamydiaceae
Genus Neisseria
Mycobacterium
Sepsis (including suspected case)
Malignant neoplasm
Severe or uncontrolled metabolic or endocrinal disorders
Connective tissue diseases
Hematologic diseases (other than chronic thrombocytopenia)
Hepatic disorders
Transmissible spongiform encephalopathy (including suspected case)
Dementia or cognitive impairment
Particular or genetic/hereditary disorders (including suspected case with familial history)
Target sample size
1
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
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
kojieto@cira.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency (JST)
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
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（京都府）
（Kyoto University Hospital, Kyoto, Japan）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | 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
1
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
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2013 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 20 | Day |
Last modified on
| 2019 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013168
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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