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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018969
Receipt No. 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

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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
Email 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
Email kanji_oshima@jpte.co.jp

Sponsor
Institute Japan Tissue Engineering Co.,Ltd.
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021950

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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