UMIN-CTR Clinical Trial

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
Email	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
Email	nishiguchi@oph.med.tohoku.ac.jp

Sponsor
Institute	Laboretory for Retinal Regeneration Riken Center for Developmental Biology
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024360