Unique ID issued by UMIN | UMIN000028324 |
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Receipt number | 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 | 2020/08/03 09:07:24 |
Investigator Initiated Trial of Cultivated Human Corneal Endothelial Cell Injection
Investigator Initiated Trial of Cultivated Human Corneal Endothelial Cell Injection
Investigator Initiated Trial of Cultivated Human Corneal Endothelial Cell Injection
Investigator Initiated Trial of Cultivated Human Corneal Endothelial Cell Injection
Japan |
bullous keratopathy
Ophthalmology |
Others
NO
To verify the efficacy and the safety of human cultured corneal endothelial cell transplantation with 3 different volume of cells
Safety,Efficacy
Exploratory
Explanatory
Phase II
Corneal Endothelial Cell Density > 1000 cells/mm^2 (12W)
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)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Dose comparison
YES
NO
Institution is considered as a block.
YES
Central registration
3
Treatment
Other |
Low volume of cells
Middle volume of cells
High volume of cells
20 | years-old | <= |
90 | years-old | > |
Male and Female
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
corneal infection
pregnant
uncontrolable glaucoma
uncontrolable diabetes
drug hypersensitivity
autoimmune disease
under another trial
cancer patient
heart disease
difficult-to-prone maintain
15
1st name | Shigeru |
Middle name | |
Last name | Kinoshita |
Kyoto Prefectural University of Medicine
Department of Frontier Medical Science and Technology for Ophthalmology
6028566
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
075-251-5772
chcec@koto.kpu-m.ac.jp
1st name | Kojiro |
Middle name | |
Last name | Imai |
Kyoto Prefectural University of Medicine
Department for Medical Innovation and Translational Medical Science
6028566
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
075-251-5308
http://www.ophth.kpu-m.ac.jp/research/kakumaku/cyunyu/
chcec@koto.kpu-m.ac.jp
Kyoto Prefectural University of Medicine
Department of Frontier Medical Science and Technology for Ophthalmology
Japan Agency for Medical Research and Development
Japanese Governmental office
Japan
KPUM IRB
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
075-251-5873
chikenjm@koto.kpu-m.ac.jp
NO
京都府立医科大学附属病院(京都府) / University Hospital Kyoto Prefectural University of Medicine
2017 | Year | 07 | Month | 21 | Day |
Unpublished
15
Completed
2017 | Year | 02 | Month | 16 | Day |
2017 | Year | 03 | Month | 07 | Day |
2017 | Year | 07 | Month | 24 | Day |
2018 | Year | 11 | Month | 19 | Day |
2017 | Year | 07 | Month | 21 | Day |
2020 | Year | 08 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032417
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