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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039133
Receipt No. R000044635
Scientific Title Establishment of disease specific iPS cells and analysis of the pathology
Date of disclosure of the study information 2020/01/20
Last modified on 2020/01/12

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Basic information
Public title Establishment of disease specific iPS cells and analysis of the pathology
Acronym disease specific iPS cells
Scientific Title Establishment of disease specific iPS cells and analysis of the pathology
Scientific Title:Acronym disease specific iPS cells
Region
Japan

Condition
Condition Spinal Muscular Atrophy, Muscular dystrophy, Normal tension glaucoma, Primary immunodeficiency disease, Li-Fraumeni syndrome, Shwachman-Diamond syndrome, Drug-induced acute pancreatitis, Lung-disease
Classification by specialty
Hepato-biliary-pancreatic medicine Pneumology Hematology and clinical oncology
Neurology Pediatrics Ophthalmology
Orthopedics Adult Child
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To establish disease specific iPS cells and its disease model systems. To evaluate the pathological mechanisms or exploring therapeutic agents.
Basic objectives2 Others
Basic objectives -Others Pathology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Analysis of the phenotype of differentiated cells derived from patients
Key secondary outcomes

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 Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 harvest skin sample from patients
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who have been confirmed clinically and molecularly biology with refractory disease. Patients who have established disease-specific iPS cells after informed consent at an external research institution.
Key exclusion criteria Patients who are judged inappropriate by the doctor's judgment. Patients infected with human immunodeficiency virus, human hepatitis B virus, and human hepatitis C virus.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Michinori
Middle name
Last name Funato
Organization National Hospital Organization, Nagara Medical Center
Division name Department of Clinical Research
Zip code 502-8558
Address 1300-7, Nagara, Gifu
TEL 058-232-7755
Email mfunato@mac.com

Public contact
Name of contact person
1st name Michinori
Middle name
Last name Funato
Organization National Hospital Organization, Nagara Medical Center
Division name Department of Clinical Research
Zip code 502-8558
Address 1300-7, Nagara, Gifu
TEL 058-232-7755
Homepage URL
Email mfunato@mac.com

Sponsor
Institute National Hospital Organization, Nagara Medical Center
Institute
Department

Funding Source
Organization National Hospital Organization, Nagara Medical Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Gifu Pharmaceutical University, Osaka Toneyama Medical Center, Tokyo Medical Center, Kobe University, Kanazawa University, Kyoto University, Gifu University
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Hospital Organization, Nagara Medical Center
Address 1300-7, Nagara, Gifu
Tel 058-232-7755
Email mfunato@mac.com

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

Other administrative information
Date of disclosure of the study information
2020 Year 01 Month 20 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 Open public recruiting
Date of protocol fixation
2019 Year 10 Month 01 Day
Date of IRB
2019 Year 11 Month 18 Day
Anticipated trial start date
2019 Year 11 Month 18 Day
Last follow-up date
2025 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In this study, somatic cells will be collected after obtaining consent from the patient or his / her sponsor. At that time, as much as possible, somatic cells use blood or milk teeth after natural tooth extraction, but due to problems such as establishment efficiency, skin fragments may be collected according to the skin biopsy method.
After that, in the culture room of the research building, reprogramming factors are introduced into patient somatic cells (skin fibroblasts, blood cells, milk teeth, etc.) to establish patient disease-specific iPS cells and induce differentiation into diseased cells. Analyze pathological conditions and search for therapeutic drugs.

Management information
Registered date
2020 Year 01 Month 12 Day
Last modified on
2020 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044635

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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