UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039133 |
|---|---|
| Receipt number | 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 19:00:50 |
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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
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
mfunato@mac.com
Sponsor or person
Institute
National Hospital Organization, Nagara Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044635
