UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012260
Receipt number R000014340
Scientific Title Clinical trial of cultivated autologous oral mucosal epithelial cell sheet transplantation for corneal epithelial stem cell deficiency
Date of disclosure of the study information 2013/11/11
Last modified on 2018/10/18 11:10:16

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Basic information

Public title

Clinical trial of cultivated autologous oral mucosal epithelial cell sheet transplantation for corneal epithelial stem cell deficiency

Acronym

Cultivated oral mucosal epithelial cell sheet transplantation

Scientific Title

Clinical trial of cultivated autologous oral mucosal epithelial cell sheet transplantation for corneal epithelial stem cell deficiency

Scientific Title:Acronym

Cultivated oral mucosal epithelial cell sheet transplantation

Region

Japan


Condition

Condition

Corneal epithelial stem cell deficiency: Patients who have dysfunction of the entire limbus with almost replaced by conjunctival epithelium, neovascularization and corneal scarring tissue.

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of cultivated autologous oral mucosal epithelial cell sheet transplantation.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To evaluate a size of epithelial defect and conjunctivalized corneal surface area in first postoperative year.

Key secondary outcomes

1. Improved visual acuity
2. Improved corneal opacity
3. Improved corneal neovascularization
4. Expected eye complications
5. All adverse events


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

Medicine Maneuver

Interventions/Control_1

Harvest of the oral mucosal tissue is conducted at the University of Tokyo Hospital. The tissue is transferred to Osaka University Hospital, and oral mucosal cell sheets are produced. The produced sheets are transferred back to the University of Tokyo Hospital, and transplanted to the cornea defected corneal epithelial stem-cell; then graft survival and stabilization of epithelial cells are attained.

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Total limbal stem cell deficiency
2) Entire corneal surface is covered by conjunctival tissue
3) Regardless of gender, and must be over 20 years old when the subjects agree with this project
4) The signed consent is required

Key exclusion criteria

1) Subjects who are pregnant, plan to become pregnant, or are breast-feeding.
2) Subjects who have systemic infections (HBV, HCV, HIV, HTLV-1)
3) Subjects who have extremely severe dry eye
4) Subjects who have extensive oral mucosal scarring and impossible to obtain the oral mucosal tissue.
5) Subjects who are not unsuitable for this project by some complications (judged by the doctor in charge).

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tomohiko Usui

Organization

Graduate School of Medicine and Faculty of Medicine, The University of Tokyo

Division name

Department of Ophthalmology

Zip code


Address

7-3-1, Hongo, Bunkyo-ku, Tokyo

TEL

03-3815-5411

Email

tomohiko-tky@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomohiko Usui

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Department of Ophthalmology

Zip code


Address

7-3-1, Hongo, Bunkyo-ku, Tokyo

TEL

03-3815-5411

Homepage URL


Email

tomohiko-tky@umin.ac.jp


Sponsor or person

Institute

Department of Ophthalmology, Graduate School of Medicine, The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

Grant for Translational Research Network Program

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Department of Ophthalmology, Osaka University Graduate School of Medicine

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

東京大学医学部附属病院(東京都)


Other administrative information

Date of disclosure of the study information

2013 Year 11 Month 11 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

2012 Year 11 Month 27 Day

Date of IRB


Anticipated trial start date

2012 Year 12 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

2013 Year 11 Month 11 Day

Last modified on

2018 Year 10 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014340


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name