UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012534 |
|---|---|
| Receipt number | R000014592 |
| Scientific Title | Clinical application of corneal endothelial regenerative medicine by means of cultured human corneal endothelial cell transplantation |
| Date of disclosure of the study information | 2013/12/09 |
| Last modified on | 2024/10/15 09:31:05 |
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Basic information
Public title
Clinical application of corneal endothelial regenerative medicine by means of cultured human corneal endothelial cell transplantation
Acronym
Clinical application of corneal endothelial regenerative medicine by means of cultured human corneal endothelial cell transplantation
Scientific Title
Clinical application of corneal endothelial regenerative medicine by means of cultured human corneal endothelial cell transplantation
Scientific Title:Acronym
Clinical application of corneal endothelial regenerative medicine by means of cultured human corneal endothelial cell transplantation
Region
| Japan |
Condition
Condition
Bullous Keratopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the efficacy of human cultured corneal endothelial cell transplantation, and the safety of cultured corneal endothelial transplantation will be verified.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Corneal Endothelial Cell Density > 500 cells/mm2 (24W)
Key secondary outcomes
Corneal Thickness < 630 micro meter and no corneal epithelial edema
Improvement of visual acuity (24W)
Improvement of VFQ-25 (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
| Medicine |
Interventions/Control_1
ROCK inhibitor
caltivated human corneal endothelial cell
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 thickness over 630 micro meter with corneal epithelial edema
corneal endothelial cell density unmesurable or under 500cells per mm2
Key exclusion criteria
corneal infection
pregnant
bleeding tendency
mental disability
uncontrolable glaucoma
uncontrolable diabetes
autoimmune disease
cancer patient
heart disease
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Kinoshita |
Organization
Kyoto Prefectural University of Medicine
Division name
Frontier Medical Science and Technology for Ophthalmology
Zip code
6028566
Address
465 Kajii-cho, kamigyo-ku, Kyoto-shi,Kyoto
TEL
075-251-5578
shigeruk@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Morio |
| Middle name | |
| Last name | Ueno |
Organization
Kyoto Prefectural University of Medicine
Division name
Ophthalmology
Zip code
6028566
Address
465 Kajii-cho, kamigyo-ku, Kyoto-shi,Kyoto
TEL
075-251-5578
Homepage URL
mueno@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
MHLW
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 Kajii-cho kamigyo-ku
Tel
+81752515337
rinri@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
| 2013 | Year | 12 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
https://www.nejm.org/doi/10.1056/NEJMoa1712770?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_d
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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2012 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 05 | 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
| 2013 | Year | 12 | Month | 09 | Day |
Last modified on
| 2024 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014592
