UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trial of cultivated autologous oral mucosal epithelial cell sheet transplantation for corneal epithelial stem cell deficiency
Title of the study (Brief title)	Cultivated oral mucosal epithelial cell sheet transplantation
Region	Japan

Condition
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

Objectives
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

Assessment
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

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	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

Eligibility
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

Research contact person
Name of lead principal investigator	Kohji Nishida
Organization	Osaka University Graduate School of Medicine
Division name	Department of Ophthalmology
Address	2-2, Yamada-oka, Suita, Osaka
TEL	+81-6-6879-3456
Email	knishida@ophthal.med.osaka-u.ac.jp

Public contact
Name of contact person	Takeshi Soma
Organization	Osaka University Graduate School of Medicine
Division name	Department of Ophthalmology
Address	2-2, Yamada-oka, Suita, Osaka
TEL	+81-6-6879-3456
Homepage URL
Email	soma@ophthal.med.osaka-u.ac.jp

Sponsor
Institute	Department of Ophthalmology, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Grant from Osaka University Hospital
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	大阪大学医学部附属病院（大阪府）

Other administrative information
Date of disclosure of the study information	2011 Year 04 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 01 Month 04 Day
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

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Publication of results	Unpublished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

Management information
Registered date	2011 Year 04 Month 07 Day
Last modified on	2017 Year 10 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006407