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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028324
Receipt No. R000032417
Scientific Title Investigator Initiated Trial of Cultivated Human Corneal Endothelial Cell Injection
Date of disclosure of the study information 2017/07/21
Last modified on 2018/01/15

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Basic information
Public title Investigator Initiated Trial of Cultivated Human Corneal Endothelial Cell Injection
Acronym Investigator Initiated Trial of Cultivated Human Corneal Endothelial Cell Injection
Scientific Title Investigator Initiated Trial of Cultivated Human Corneal Endothelial Cell Injection
Scientific Title:Acronym Investigator Initiated 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 verify the efficacy and the safety of human cultured corneal endothelial cell transplantation with 3 different volume of cells
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Corneal Endothelial Cell Density > 1000 cells/mm^2 (12W)
Key secondary outcomes Corneal Endothelial Cell Density > 1000 cells/mm^2 (52W)
Corneal Thickness < 630 micro meter and no corneal epithelial edema(12, 52W)
Improvement of visual acuity (12, 52W)
Improvement of VFQ-25 (12, 52W)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Dose comparison
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Low volume of cells
Interventions/Control_2 Middle volume of cells
Interventions/Control_3 High volume of cells
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
cancer patient
heart disease
difficult-to-prone maintain
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Kinoshita
Organization Kyoto Prefectural University of Medicine
Division name Department of Frontier Medical Science and Technology for Ophthalmology
Zip code
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
Middle name
Last name Kojiro Imai
Organization Kyoto Prefectural University of Medicine
Division name Department for Medical Innovation and Translational Medical Science
Zip code
Address 465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL 075-251-5308
Homepage URL http://www.ophth.kpu-m.ac.jp/research/kakumaku/cyunyu/
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 Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 京都府立医科大学附属病院(京都府) / University Hospital Kyoto Prefectural University of Medicine

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 21 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 No longer recruiting
Date of protocol fixation
2017 Year 02 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 21 Day
Last modified on
2018 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032417

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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