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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000012264
Receipt No. R000014328
Scientific Title Clinical trial of cultivated autologous oral mucosal epithelial cell sheet transplantation for corneal epithelial stem cell deficiency
Date of disclosure of the study information 2013/11/11
Last modified on 2016/05/11

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Basic information
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
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 in Ehime University Hospital. The tissue is transferred to Osaka University Hospital, and oral mucosal cell sheets are produced. The produced sheets are transferred back to the Ehime University Hospital, and 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) 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
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 impossible to obtain the oral mucosal tissue.
5) Subjects who are not unsuitable for this project by some complications (judged by the doctor in charge).
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichi Ohashi
Organization Ehime University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code
Address Shitsukawa, Toon, Ehime
TEL 089-960-5361
Email ohashi@m.ehime-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Shiraishi
Organization Ehime University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code
Address Shitsukawa, Toon, Ehime
TEL 089-960-5361
Homepage URL
Email shiraia@m.ehime-u.ac.jp

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

Funding Source
Organization Grant for Translational Research Network Program
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Ophthalmology, Osaka University Graduate School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 愛媛大学医学部附属病院(愛媛県)

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 11 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2012 Year 11 Month 27 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 11 Month 11 Day
Last modified on
2016 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014328

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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