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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005400
Receipt No. R000006407
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 2011/04/08
Last modified on 2017/10/10

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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 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
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

Public contact
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

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)

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 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

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 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
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

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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