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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024360


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name