UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053412 |
|---|---|
| Receipt number | R000060940 |
| Scientific Title | Investigator Initiated Explaratory and Confirmatory Trial of Cultivated Human Corneal Endothelial Cell Injection: long-term follow up |
| Date of disclosure of the study information | 2024/01/23 |
| Last modified on | 2024/01/19 17:08:49 |
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Basic information
Public title
Investigator Initiated Explaratory and Confirmatory Trial of Cultivated Human Corneal Endothelial Cell Injection: long-term follow up
Acronym
Investigator Initiated Explaratory and Confirmatory Trial of Cultivated Human Corneal Endothelial Cell Injection: long-term follow up
Scientific Title
Investigator Initiated Explaratory and Confirmatory Trial of Cultivated Human Corneal Endothelial Cell Injection: long-term follow up
Scientific Title:Acronym
Investigator Initiated Explaratory and Confirmatory Trial of Cultivated Human Corneal Endothelial Cell Injection: long-term follow up
Region
| Japan |
Condition
Condition
bullous keratopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the long-term efficacy and safety of cultured human corneal endothelial cell transplantation after investigator initiated clinical trials.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Corneal endothelial cell density
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1. The patient who underwent cultured human corneal endothelial transplantation as investigator initiated clinical trials
2. Obtained informed consent to participate this study
Key exclusion criteria
The patient who was judged as inappropriate
Target sample size
27
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
+81-75-251-5772
shigeruk@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-shi, Kyoto
TEL
+81-75-251-5308
Homepage URL
chcec@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Kyoto Prefectural University of Medicine
Address
465 Kajiicho, Hirokoji, Kawaramachi, Kamigyoku, Kyoto
Tel
+81-75-251-5337
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
| 2024 | Year | 01 | Month | 23 | 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
27
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
| 2020 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Main observations: corneal endothelial cell density and safety data
Management information
Registered date
| 2024 | Year | 01 | Month | 22 | Day |
Last modified on
| 2024 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060940
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
