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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038345
Receipt No. R000043701
Scientific Title Cultivated oral mucosal epithelial transplantation in severe ocular surface diseases, phase-3 study: a follow up study
Date of disclosure of the study information 2019/12/01
Last modified on 2019/10/21

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Basic information
Public title Cultivated oral mucosal epithelial transplantation in severe ocular surface diseases, phase-3 study: a follow up study
Acronym Cultivated oral mucosal epithelial transplantation, phase-3 study: a follow up study
Scientific Title Cultivated oral mucosal epithelial transplantation in severe ocular surface diseases, phase-3 study: a follow up study
Scientific Title:Acronym Cultivated oral mucosal epithelial transplantation, phase-3 study: a follow up study
Region
Japan

Condition
Condition severe ocular surface diseases
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Long term observation of efficacy and safety in cultivated oral mucosal epithelial transplantation as mucosal epithelial supply treatment
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of adhesion score decided by an independent committee (52W)
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
15 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria 1. The patient who underwent cultivated oral mucosal epithelial transplantation
2. Obtained informed consent to participate this study
Key exclusion criteria The patient who was judged as inappropriate
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
Email 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
Email kpum_comet-office@umin.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto Prefectural University of Medicine, Institutional Review Board
Address 465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
Tel 075-251-5337
Email 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
2019 Year 12 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 Preinitiation
Date of protocol fixation
2019 Year 11 Month 29 Day
Date of IRB
Anticipated trial start date
2019 Year 12 Month 02 Day
Last follow-up date
2020 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Main observations: the change of adhesion score and safety data

Management information
Registered date
2019 Year 10 Month 21 Day
Last modified on
2019 Year 10 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043701

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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