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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034334
Receipt No. R000039139
Scientific Title Investigator Initiated Confirmatory Trial of Cultivated Human Corneal Endothelial Cell Injection
Date of disclosure of the study information 2018/10/01
Last modified on 2019/05/21

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Basic information
Public title Investigator Initiated Confirmatory Trial of Cultivated Human Corneal Endothelial Cell Injection
Acronym Investigator Initiated Confirmatory Trial of Cultivated Human Corneal Endothelial Cell Injection
Scientific Title Investigator Initiated Confirmatory Trial of Cultivated Human Corneal Endothelial Cell Injection
Scientific Title:Acronym Investigator Initiated Confirmatory Trial of Cultivated Human Corneal Endothelial Cell Injection
Region
Japan

Condition
Condition bullous keratopathy
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the efficacy and the safety of human cultured corneal endothelial cell transplantation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Corneal Endothelial Cell Density > 1000 cells/mm^2 (24W)
Key secondary outcomes Corneal Thickness < 630 micro meter and no corneal epithelial edema(24W)
Improvement of visual acuity (24W)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 fixed volume of cells
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
90 years-old >
Gender Male and Female
Key inclusion criteria BSCVA under 0.5
corneal endothelial cell density unmeasurable or under 500cells per mm^2
corneal thickness over 630 micro meter with corneal epithelial edema
Key exclusion criteria corneal infection
pregnant
uncontrolable glaucoma
uncontrolable diabetes
drug hypersensitivity
autoimmune disease
under another trial
treated by cultivated human corneal endothelial cell injection to another eye within 52W
cancer patient
heart disease
difficult-to-prone maintain
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Shigeru
Middle name
Last name Kinoshita
Organization Kyoto Prefectural University of Medicine
Division name Department of Frontier Medical Science and Technology for Ophthalmology
Zip code 6028566
Address 465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL 075-251-5772
Email chcec@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name Kojiro
Middle name
Last name Imai
Organization Kyoto Prefectural University of Medicine
Division name Department for Medical Innovation and Translational Medical Science
Zip code 6028566
Address 465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL 075-251-5308
Homepage URL
Email chcec@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Department of Frontier Medical Science and Technology for Ophthalmology
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization KPUM IRB
Address 465 Kawaramachi Kamigyo-Ku Kyoto
Tel 075-251-5873
Email n-aya@koto.kpu-m.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
2018 Year 10 Month 01 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 13
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 No longer recruiting
Date of protocol fixation
2018 Year 07 Month 19 Day
Date of IRB
2018 Year 08 Month 09 Day
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
2019 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 30 Day
Last modified on
2019 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039139

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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