UMIN-CTR Clinical Trial

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
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	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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039143