UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012014 |
|---|---|
| Receipt number | R000014040 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2013/10/10 |
| Last modified on | 2018/10/18 11:09:47 |
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Basic information
Public title
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
Acronym
Xeno-free cultivated corneal limbal epithelial cell sheet transplantation
Scientific Title
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
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Satoru Yamagami |
Organization
The University of Tokyo Hospital
Division name
Department of Corneal Transplantation
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
syamagami-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiko Usui |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Ophthalmology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
tomohiko-tky@umin.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2013 | Year | 05 | Month | 15 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014040
