UMIN-CTR Clinical Trial

Public title

Exploratory clinical trial of serum-, and feeder cell-free cultivated autologous corneal limbal epithelial cell sheet transplantation using human amniotic membrane for corneal epithelial stem-cell deficiency

Acronym

Xeno-free cultivated corneal limbal epithelial cell sheet transplantation

Scientific Title

Exploratory clinical trial of serum-, and feeder cell-free cultivated autologous corneal limbal epithelial cell sheet transplantation using human amniotic membrane for corneal epithelial stem-cell deficiency

Scientific Title:Acronym

Xeno-free cultivated corneal limbal epithelial cell sheet transplantation

Region

Japan

Condition

Unilateral 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

Narrative objectives1

To evaluate the safety of serum-, and feeder cell-free cultivated autologous corneal limbal epithelial cell sheet transplantation using human amniotic membrane

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

To evaluate the existence of omission of the transplanted cell sheet, expected eye complications, and all adverse events including a laboratory test abnormality

Key secondary outcomes

1. To evaluate the area without epithelial defect or conjunctivalization
2. Improved visual acuity
3. Improved corneal opacity
4. Improved corneal neovascularization

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

Device,equipment

Maneuver

Interventions/Control_1

Corneal limbal epithelial tissue is extracted from a patient's own healthy eye, and a limbal epithelial cell sheet using human amniotic membrane is produced. The produced sheet is 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) Unilateral limbal stem cell deficiency
2) Unilateral 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 has not passed for six months after undergoing the next operation on the eye which is due to be transplanted; conjunctival sac plasty, amnion transplant of sclera, mitomycin-C treatment
5) Subjects who are not unsuitable for this project by some complications (judged by the docter in charge).

Target sample size

3

Name of lead principal investigator

1st name
Middle name
Last name	Satoru Yamagami

Organization

The University of Tokyo Hospital

Division name

Department of Corneal Transplantation

Zip code

Address

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

TEL

03-3815-5411

Email

syamagami-tky@umin.ac.jp

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

Institute

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

Institute

Department

Personal name

Organization

Grant for Translational Research Network Program

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京大学医学部附属病院（東京都）

Date of disclosure of the study information

2013

Year

10

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2013

Year

05

Month

15

Day

Date of IRB

Anticipated trial start date

2014

Year

01

Month

06

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

10

Month

10

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=R000014040