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

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 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

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

Value
https://center6.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