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 of the out patient unit of department of ophthalmology or medical center for translational research in Osaka University Hospital. The safety of harvest process of the oral mucosal tissue is evaluated carefully. The oral mucosal tissue is harvested from the cheek mucosa after local anesthesia. The size of the oral mucosal tissue would be 5 mm square and 3-4 mm in depth. The site of harvest is sutured for blood stanching and observed during the early follow-up period.

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

At least one eye have to fully meet the criteria

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 impossibile to obtain the oral mucosal tissue.
5) Subjects whose performance status is scored over 3 points.
6) Subjects who are not unsuitable for this project by some complications (judged by the docter in charge).

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Kohji Nishida

Organization

Osaka University Graduate School of Medicine

Division name

Department of Ophthalmology

Zip code

Address

2-2, Yamada-oka, Suita, Osaka

TEL

+81-6-6879-3456

Email

knishida@ophthal.med.osaka-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Takeshi Soma

Organization

Osaka University Graduate School of Medicine

Division name

Department of Ophthalmology

Zip code

Address

2-2, Yamada-oka, Suita, Osaka

TEL

+81-6-6879-3456

Homepage URL

Email

soma@ophthal.med.osaka-u.ac.jp

Institute

Department of Ophthalmology, Osaka University Graduate School of Medicine

Institute

Department

Personal name

Organization

Grant from Osaka University Hospital

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

大阪大学医学部附属病院（大阪府）

Date of disclosure of the study information

2011

Year

04

Month

08

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

2011

Year

01

Month

04

Day

Date of IRB

Anticipated trial start date

2011

Year

05

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

04

Month

07

Day

Last modified on

2017

Year

10

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006407