UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011542 |
|---|---|
| Receipt number | R000013490 |
| Scientific Title | Development of human cellular models for motor neuron diseases using disease-specific induced pluripotent stem (iPS) cells |
| Date of disclosure of the study information | 2013/09/01 |
| Last modified on | 2018/03/06 08:40:17 |
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Basic information
Public title
Development of human cellular models for motor neuron diseases using disease-specific induced pluripotent stem (iPS) cells
Acronym
Development of cellular models for motor neuron diseases from iPS cells
Scientific Title
Development of human cellular models for motor neuron diseases using disease-specific induced pluripotent stem (iPS) cells
Scientific Title:Acronym
Development of cellular models for motor neuron diseases from iPS cells
Region
| Japan |
Condition
Condition
Adult-onset motor neuron diseases (MND) including sporadic or familial amyotrophic lateral sclerosis (ALS) and spinal muscular atrophy (SMA) type IV
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to clarify pathomechanism underlying ALS/MND, patient-derived disease-specific iPS cells are generated and used to develop human cellular models reproducing the disease phenotype.
Basic objectives2
Others
Basic objectives -Others
Biological property of neural cells differentiated from ALS/MND-specific iPS cells
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Biological property of cultured neural cells differentiated from ALS/MND-specific iPS cells, such as cellular morphology, neurite elongation, synaptogenesis, and action potentials
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
- Clinically diagnosed as sporadic/familial (hereditary) ALS or spinal muscular atrophy type IV, based on the guide to diagnosis and medical care by the Ministry of Health, Labour and Welfare, Japan
- Confirmed gene mutations in case of familial (hereditary) ALS
- Obtained informed consent in writing
Key exclusion criteria
- Presence of dementia
- Difficulty in sampling
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Aoki, MD, PhD |
Organization
Tohoku University Graduate School of Medicine
Division name
Neurology
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan
TEL
+81-22-717-7000
admin@neurol.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Warita, MD, PhD |
Organization
Tohoku University Graduate School of Medicine
Division name
Neurology
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan
TEL
+81-22-717-7000
Homepage URL
warita-ns@umin.net
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT) of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Institute of Neuroscience, National Center of Neurology and Psychiatry (NCNP) and
Department of Physiology, Keio University School of Medicine
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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/26997647
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
Completed
Date of protocol fixation
| 2010 | Year | 10 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
- observational study
- prospective study
Management information
Registered date
| 2013 | Year | 08 | Month | 21 | Day |
Last modified on
| 2018 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013490
