UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038561 |
|---|---|
| Receipt number | R000043946 |
| Scientific Title | The study of therapeutic drug development with neurodegenerative diseases by using iPS cells derived from patients' samples. |
| Date of disclosure of the study information | 2019/11/13 |
| Last modified on | 2023/05/16 09:32:18 |
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Basic information
Public title
The study of therapeutic drug development with neurodegenerative diseases by using iPS cells derived from patients' samples.
Acronym
The study of therapeutic drug development with neurodegenerative diseases by using iPS cells derived from patients' samples.
Scientific Title
The study of therapeutic drug development with neurodegenerative diseases by using iPS cells derived from patients' samples.
Scientific Title:Acronym
The study of therapeutic drug development with neurodegenerative diseases by using iPS cells derived from patients' samples.
Region
| Japan |
Condition
Condition
Neurodegenerative diseases
Classification by specialty
| Neurology | Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The study of therapeutic drug development with neurodegenerative diseases by using iPS cells derived from patients' samples. Several candidate drugs or therapeutics (middle molecular compound, Stem cells from human exfoliated deciduous teeth-conditioned medium; SHED-CM, genome editing technology) are examined by using iPS cells.
Basic objectives2
Others
Basic objectives -Others
To establish in vitro human experimental model for neurodegenerative diseases.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To lay the foundation for future researches of drug development for neurodegenerative diseases.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
<Amyotrophic lateral sclerosis (ALS)>
Clinical feature or electrophysiological abnormality from upper and lower motor neuron disorder.
Clinical feature of upper motor neuron disorder is determined as pathological reflex and clonus.
Clinical feature of lower motor neuron disorder is determined as muscular weakness, amyotrophy, and muscular fasciculation.
<Idiopathic basal ganglia calcification (IBGC)>
Conspicuous calcification is observed in the basal ganglia and/or dentate nucleus on CT scanning image.
Calcification is bilateral and symmetrical.
Idiopathic (absence of biochemical abnormalities, and an infections, toxic, or traumatic cause).
Key exclusion criteria
<Amyotrophic lateral sclerosis (ALS)>
Exclude the following diseases.
Other motor neuron disorders, motor neurophathy, cervical spondylosis, and inflammatory myopathy such as inclusion body myositis.
<Idiopathic basal ganglia calcification (IBGC)>
To exclude diseases which show calcification, because of some causes such as hypoparathyroism, pseudo hypoparathyroism, pseudopseudo hypoparathyroism (Albright's osteodystrophy), Down syndrome, collagen diseases, angiitis, infections, intoxication, trauma, radiation therapy and so on.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Isao |
| Middle name | |
| Last name | Hozumi |
Organization
Gifu Pharmaceutical University
Division name
Laboratory of Medical Therapeutics and Molecular Therapeutics
Zip code
501-1196
Address
1-25-4 Daigaku-Nishi Gifu city, Gifu Prefecture, JAPAN 501-1196
TEL
058-230-8121
hozumi@gifu-pu.ac.jp
Public contact
Name of contact person
| 1st name | Isao |
| Middle name | |
| Last name | Hozumi |
Organization
Gifu Pharmaceutical University
Division name
Laboratory of Medical Therapeutics and Molecular Therapeutics
Zip code
501-1196
Address
1-25-4 Daigaku-Nishi Gifu city, Gifu Prefecture, JAPAN 501-1196
TEL
058-230-8121
Homepage URL
hozumi@gifu-pu.ac.jp
Sponsor or person
Institute
Gifu Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of education, culture, sports, science and technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Japan Agency for Medical Research and Development
IRB Contact (For public release)
Organization
Ethics Committee of Gifu Pharmaceutical University
Address
1-25-4 Daigaku-Nishi Gifu city, Gifu Prefecture, JAPAN 501-1196
Tel
058-230-8100
syomuk@gifu-pu.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 13 | 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
| 2013 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2013 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
To lay the foundation for future researches of drug development for neurodegenerative diseases.
Management information
Registered date
| 2019 | Year | 11 | Month | 12 | Day |
Last modified on
| 2023 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043946
| 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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