UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034334 |
|---|---|
| Receipt number | 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 | 2020/08/03 09:11:47 |
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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
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
chcec@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Department of Frontier Medical Science and Technology for Ophthalmology
Institute
Department
Personal name
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
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
12
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
Completed
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 | 07 | Month | 08 | 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
| 2020 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.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 |
