UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034335 |
|---|---|
| Receipt number | R000039143 |
| Scientific Title | Cultivated oral mucosal epithelial transplantation in severe ocular surface diseases, phase-3 study |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2020/08/03 09:19:56 |
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Basic information
Public title
Cultivated oral mucosal epithelial transplantation in severe ocular surface diseases, phase-3 study
Acronym
Cultivated oral mucosal epithelial transplantation, phase-3 study
Scientific Title
Cultivated oral mucosal epithelial transplantation in severe ocular surface diseases, phase-3 study
Scientific Title:Acronym
Cultivated oral mucosal epithelial transplantation, phase-3 study
Region
| Japan |
Condition
Condition
severe ocular surface diseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirmation of efficacy and safety in cultivated oral mucosal epithelial transplantation as mucosal epithelial supply treatment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
The change of adhesion score decided by an independent committee (24W)
Key secondary outcomes
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
Confirmation for efficacy and safety of cultivated oral mucosal epithelial transplantation as mucosal epithelial supply treatment
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
| 15 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
severe ocular surface diseases with advanced adhesion score
another eye tissue is unavailable
adhesion score is more than 4
stable condition within 4W
Key exclusion criteria
corneal infection or uncontrolable glaucoma in the target eye
Difficulty with the collection of oral mucosal epithelia
drug or xenogeneic protein hypersensitivity
uncontrolable diabetes
infection with virus or syphilis
pregnant
pretreated for the target eye, or under another trial
difficulty with keeping trial procedures
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | Chie |
| Middle name | |
| Last name | Sotozono |
Organization
Kyoto Prefectural University of Medicine Hospital
Division name
Ophthalmology
Zip code
6028566
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5578
kpum_comet-office@umin.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
kpum_comet-office@umin.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
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, Kajii-cho, Kamigyo-ku, Kyoto
Tel
075-251-5873
chikenjm@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
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 | 08 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 12 | 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=R000039143
