UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002948 |
|---|---|
| Receipt number | R000003586 |
| Scientific Title | Cultivated epithelial sheet transplantation for corneal epithelial stem cell deficiency |
| Date of disclosure of the study information | 2009/12/29 |
| Last modified on | 2017/01/05 09:21:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Cultivated epithelial sheet transplantation for corneal epithelial stem cell deficiency
Acronym
Cultivated corneal epithelial sheet transplantation
Scientific Title
Cultivated epithelial sheet transplantation for corneal epithelial stem cell deficiency
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Kazuo Tsubota |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
03-3353-1211
tsubota@z3.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeto Shimmura |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
03-3353-1211
Homepage URL
shige@z8.keio.jp
Sponsor or person
Institute
Department of Ophthalmology, Keio University School of Medicine
Institute
Department
Personal name
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)
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
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 |
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
| 2012 | Year | 12 | Month | 21 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003586
