UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018969 |
|---|---|
| Receipt number | R000021950 |
| Scientific Title | Multicenter clinical trial using cultivated autologous corneal epithelium (EYE-01M) transplantation for patients with limbal stem-cell deficiency |
| Date of disclosure of the study information | 2015/09/10 |
| Last modified on | 2019/02/14 17:32:57 |
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Basic information
Public title
Multicenter clinical trial using cultivated autologous corneal epithelium (EYE-01M) transplantation for patients with limbal stem-cell deficiency
Acronym
Multicenter clinical trial using EYE-01M for patients with limbal stem-cell deficiency
Scientific Title
Multicenter clinical trial using cultivated autologous corneal epithelium (EYE-01M) transplantation for patients with limbal stem-cell deficiency
Scientific Title:Acronym
Multicenter clinical trial using EYE-01M for patients with limbal stem-cell deficiency
Region
| Japan |
Condition
Condition
limbal stem-cell deficiency
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of cultivated autologous corneal epithelial (EYE-01M) transplantation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
success rate of corneal epithelium reconstruction 52 weeks after EYE-01M
transplantation
Key secondary outcomes
Efficacy
1) case number of each LSCD staging 52 weeks after EYE-01M transplantation
2) subjective symptom
3) visual acuity
4) QOL
5) corneal opacity
6) corneal neovascularization
7) symblepharon
8) additional therapy for visual improvement 52 weeks after EYE-01M transplantation or at the date of termination
Safety
1) Safety endpoint
i. SPK
ii. corneal epithelial defect
2) Adverse events and Product-related adverse events
3) Severe product-related 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
| Device,equipment |
Interventions/Control_1
Removal of limbal tissue, EYE-01M transplantation
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) Limbal stem-cell deficiency patients who are classified as LSCD Stage III and StageIIB that is not improved in the past three months
2) Patients who have healthy limbal of contralateral eye,and will not have trouble of tissue collection judged by principal investigator or sub-investigators
3) Aged 20 years old and over
Key exclusion criteria
1) contraindication to antimicrobials, steroid drugs, and anesthetics used in the trial
2) allergy to antibiotics of penicillin, kanamycin, streptomycin, amphotericin B; Medical history of allergy to penicillin antibiotic and aminoglycoside antibiotic
3) medical history of allergy to animal (cattle, mice, or pigs)
4) malignant tumor within 5 years before registration, or doubtful malignant tumor
5) glaucoma with uncontrollable IOP
6) diabetes with uncontrollable glycemic control
7) eye with central visual field defect
8) extremely severe dry eye
9) planned intraocular surgery during the trial
10) eye with severe eyelid defect
11) systemic complications unsuitable for entry in this trial
12) pregnant/lactating women, might be pregnant women; wish to become pregnant women
13) another trial participant within 16 weeks before EYE-01M transplantation, planning to participate in another trial during this trial
14) unsuitable for entry in this trial judged by principal investigator or sub-investigators
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeaki Hayashi |
Organization
Japan Tissue Engineering Co.,Ltd.
Division name
Clinical Development Dept.
Zip code
Address
6-209-1 Miyakitadori, Gamagori, Aichi 443-0022, Japan
TEL
0533-66-2020
shigeaki_hayashi@jpte.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ooshima Kanji |
Organization
Japan Tissue Engineering Co.,Ltd.
Division name
Clinical Development Dept.
Zip code
Address
6-209-1 Miyakitadori, Gamagori, Aichi 443-0022, Japan
TEL
0533-66-2020
Homepage URL
kanji_oshima@jpte.co.jp
Sponsor or person
Institute
Japan Tissue Engineering Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Japan Tissue Engineering Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit 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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | 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
| 2014 | Year | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 10 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 03 | Day |
Date analysis concluded
| 2019 | Year | 01 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 10 | Day |
Last modified on
| 2019 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021950
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
