UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021556 |
|---|---|
| Receipt number | R000024360 |
| Scientific Title | Generation of induced pluripotent stem cells (iPSCs) derived from intractable retinal disease patients and clarification of the diseases and novel therapies development by using retinal tissues differentiated and induced from iPSC. |
| Date of disclosure of the study information | 2016/03/22 |
| Last modified on | 2022/03/16 13:59:30 |
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Basic information
Public title
Generation of induced pluripotent stem cells (iPSCs) derived from intractable retinal disease patients and clarification of the diseases and novel therapies development by using retinal tissues differentiated and induced from iPSC.
Acronym
Generation of induced pluripotent stem cells (iPSCs) derived from intractable retinal disease patients and clarification of the diseases and novel therapies development by using retinal tissues differentiated and induced from iPSC.
Scientific Title
Generation of induced pluripotent stem cells (iPSCs) derived from intractable retinal disease patients and clarification of the diseases and novel therapies development by using retinal tissues differentiated and induced from iPSC.
Scientific Title:Acronym
Generation of induced pluripotent stem cells (iPSCs) derived from intractable retinal disease patients and clarification of the diseases and novel therapies development by using retinal tissues differentiated and induced from iPSC.
Region
| Japan |
Condition
Condition
Intractable retinal diseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarification of the diseases and novel therapies development
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparative analysis between the patients and normal people about the morphology, the function, stress response and drug screening of the retinal cells derived from iPSCs.
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
Intractable retinal diseases (glaucoma, optic nerve atrophy, retinal choroidal dystrophy, retinal degeneration disease)
20 years of age or more
Key exclusion criteria
Under 20 years of age
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Nakazawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
980-8574
Address
1-1 Seiryo-cho Aoba-ku Sendai-shi Miyagi-ken
TEL
022-717-7294
ntoru@oph.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Wataru |
| Middle name | |
| Last name | Kobayashi |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
980-8574
Address
1-1 Seiryo-cho Aoba-ku Sendai-shi Miyagi-ken
TEL
022-717-7294
Homepage URL
nishiguchi@oph.med.tohoku.ac.jp
Sponsor or person
Institute
Laboretory for Retinal Regeneration Riken Center for Developmental Biology
Institute
Department
Personal name
Funding Source
Organization
RIKEN (Institute of Physical and Chemical Research)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Ophthalmology
Tohoku University Graduate School of Medicine
Name of secondary funder(s)
Japan society for the promotion of science
Senju Pharmaceutical Co.,Ltd.
IRB Contact (For public release)
Organization
Ethics Committee, Department of Medicine, Tohoku University
Address
1-1 Seiryo-cho Aoba-ku Sendai-shi Miyagi-ken
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2016 | Year | 03 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
･Case-control study
･Doctors select the patients who meet the selection criterias and are suspected of the glaucoma hereditary from April 2019 to March 2022.
･Examination contents:Visual acuity, Intraocular pressure, Visual field test, Fundus examination, Corneal thickness, Laser Speckle Flowgraphy (LSFG), Blood sampling
Management information
Registered date
| 2016 | Year | 03 | Month | 22 | Day |
Last modified on
| 2022 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024360
