UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Cultivated epithelial sheet transplantation for corneal epithelial stem cell deficiency
Title of the study (Brief title)	Cultivated corneal epithelial sheet transplantation
Region	Japan

Condition
Condition	a) Steven's Johnson Syndrome b) Ocular cicatricial pemphigoid c) Chemical/ Thermal Burns of the Cornea d) Gelatinous Drop Like Dystrophy e) Salzmann Corneal Degeneration f) Congenital Aniridia
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of cultivated corneal epithelial sheet transplantation using human corneal epithelial stem cells and human bone marrow mesenchymal stem cell-derived feeder cells.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improved visual acuity
Key secondary outcomes

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	Corneal epithelial sheet transplantation Cultivated eptihealial sheet transplantation will be perfored in the surgical department of Keio University Hospital. Simultaneous lamellar keratoplasty will be allowed. Surgical procedure involves removal of all pannus and abnormal epithelial tissue, the use of 0.04% mitomycin C to prevent fibrosis, and transplantation of the cultivated sheet.
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	Residual tear function (Schirmer test greater than 5 mm) and normal lid anatomy.
Key exclusion criteria	(1) Corneal disease of unknown etiology (2) Active infection (3) Glaucoma (4) Diabetes mellitis with poor BS control (5) Hypersensitivity to steroids or immunosuppressants (6) Patients planned for other intraocular surgery (7) Pregnancy
Target sample size	5

Research contact person
Name of lead principal investigator	Kazuo Tsubota
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Address	35 Shinanomachi, Shinjuku, Tokyo
TEL	03-3353-1211
Email	tsubota@z3.keio.jp

Public contact
Name of contact person	Shigeto Shimmura
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Address	35 Shinanomachi, Shinjuku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	shige@z8.keio.jp

Sponsor
Institute	Department of Ophthalmology, Keio University School of Medicine
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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	慶應義塾大学医学部病院（東京都）

Other administrative information
Date of disclosure of the study information	2009 Year 12 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 12 Month 21 Day
Anticipated trial start date	2013 Year 04 Month 01 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	2009 Year 12 Month 28 Day
Last modified on	2017 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003586