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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034335
Receipt No. 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 2018/10/15

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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
Middle name
Last name Chie Sotozono
Organization Kyoto Prefectural University of Medicine Hospital
Division name Ophthalmology
Zip code
Address 465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL 075-251-5578
Email kpum_comet-office@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kojiro Imai
Organization Kyoto Prefectural University of Medicine
Division name Department for Medical Innovation and Translational Medical Science
Zip code
Address 465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL 075-251-5308
Homepage URL
Email kpum_comet-office@umin.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2018 Year 08 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
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
2018 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039143

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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