UMIN-CTR Clinical Trial

Basic information
Public title	Long-term follow-up of the multicenter clinical trial using cultivated autologous corneal epithelium (EYE-01M) transplantation for patients with limbal stem-cell deficiency
Acronym	Long-term follow-up of the multicenter clinical trial using cultivated autologous corneal epithelium (EYE-01M) transplantation for patients with limbal stem-cell deficiency
Scientific Title	Long-term follow-up of the multicenter clinical trial using cultivated autologous corneal epithelium (EYE-01M) transplantation for patients with limbal stem-cell deficiency
Scientific Title:Acronym	Long-term follow-up of the multicenter clinical trial using cultivated autologous corneal epithelium (EYE-01M) transplantation for patients with limbal stem-cell deficiency
Region	Japan

Condition
Condition	limbal stem-cell deficiency(LSCD)
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate long-term Safety and Efficacy in patients with LSCD to whom EYE-01M have been transplanted in the clinical study (protocol No. J-TEC-EYE).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	LSCD staging for 104 weeks after EYE-01M transplantation
Key secondary outcomes	Efficacy 1) LSCD staging after EYE-01M transplantation 2) subjective symptom 3) visual acuity 4) QOL 5) corneal opacity 6) corneal neovascularization 7) symblepharon 8) Contributing to the regeneration corneal epithelium in patients with additional therapy Safety 1) Number and rate of adverse events and product-related adverse events 2) Number and rate of significant 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	Maneuver
Interventions/Control_1	Observation of efficacy and safety of EYE-01M transplant patients after 78 and 104 weeks
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients enrolled in the J-TEC-EYE study and transplanted with investigational products
Key exclusion criteria	1) Patients planning to participate in other clinical trials during the study participation 2) Patients who desire pregnancy during clinical studies 3) Patients determined to be inappropriate by physicians
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Shigeaki Middle name Last name Hayashi
Organization	Japan Tissue Engineering Co., Ltd.
Division name	Clinical Development Dept.
Zip code	4430022
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 Shigeaki Middle name Last name Hayashi
Organization	Japan Tissue Engineering Co., Ltd.
Division name	Clinical Development Dept.
Zip code	443-0022
Address	6-209-1 Miyakitadori, Gamagori, Aichi 443-0022, Japan
TEL	0533-66-2020
Homepage URL
Email	shigeaki_hayashi@jpte.co.jp

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

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Osaka University Hospital
Address	2-2-2 Iida-Nishi, Yamagata City, Yamagata
Tel	06-6210-8290
Email	Jim-chikenn@hp-crc.med.osaka-u.sc.jp

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	2020 Year 03 Month 31 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	10
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Because data is being prepared.
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	2016 Year 04 Month 01 Day
Date of IRB	2017 Year 11 Month 10 Day
Anticipated trial start date	2016 Year 06 Month 17 Day
Last follow-up date	2019 Year 02 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is long-term follow-up clinical trial of EYE-01M study(UMIN000018969)

Management information
Registered date	2020 Year 03 Month 31 Day
Last modified on	2020 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045599