UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	Xeno-free cultivated corneal limbal epithelial cell sheet transplantation
Region	Japan

Condition
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

Objectives
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

Assessment
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

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	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

Eligibility
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

Research contact person
Name of lead principal investigator	Satoru Yamagami
Organization	The University of Tokyo Hospital
Division name	Department of Corneal Transplantation
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411
Email	syamagami-tky@umin.ac.jp

Public contact
Name of contact person	Tomohiko Usui
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Department of Ophthalmology
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411
Homepage URL
Email	tomohiko-tky@umin.ac.jp

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

Funding Source
Organization	Grant for Translational Research Network Program
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 10 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 10 Month 10 Day
Last modified on	2018 Year 10 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014040