UMIN-CTR Clinical Trial

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

Bilateral corneal epithelial stem cell deficiency: Patients with severe intractable ocular surface disease who have dysfunction of the entire limbus with totally replaced by conjunctival epithelium, neovascularization and corneal scarring tissue. (*Corneal epithelial stem cell deficiency: It is possible to make the diagnosis by using slit lamp microscopy showing loss of the palisades of Vogt (POV) and a conjunctivalized corneal surface which also can be seen by characteristic fluorescein staining patterns easily.)

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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 operation room in Ehime University Hospital. The tissue is transferred to Osaka University Hospital, and oral mucosal cell sheets are produced. The produced sheets are transferred back to the Ehime University 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

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

Name of lead principal investigator

1st name	Yuichi
Middle name
Last name	Ohashi

Organization

Ehime University Graduate School of Medicine

Division name

Department of Ophthalmology

Zip code

791-0295

Address

Shitsukawa, Toon, Ehime

TEL

+819011730885

Email

shiraia@m.ehime-u.ac.jp

Name of contact person

1st name	Atsushi
Middle name
Last name	Shiraishi

Organization

Ehime University Graduate School of Medicine

Division name

Department of Ophthalmology

Zip code

791-0295

Address

Shitsukawa, Toon, Ehime

TEL

+819011730885

Homepage URL

Email

shiraia@m.ehime-u.ac.jp

Institute

Department of Ophthalmology, Ehime University Graduate School of Medicine

Institute

Department

Personal name

Organization

Grant for Translational Research Network Program

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Department of Ophthalmology, Osaka University Graduate School of Medicine

Name of secondary funder(s)

Organization

Ehime University School of Medicine

Address

Shitsukawa, Toon, Ehime

Tel

0899605351

Email

shiraia@m.ehime-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

愛媛大学医学部附属病院（愛媛県）

Date of disclosure of the study information

2013

Year

11

Month

11

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

2

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

Recruitment status

Completed

Date of protocol fixation

2012

Year

11

Month

27

Day

Date of IRB

2012

Year

10

Month

20

Day

Anticipated trial start date

2013

Year

03

Month

12

Day

Last follow-up date

2022

Year

10

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

11

Month

11

Day

Last modified on

2023

Year

05

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014328