UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039994 |
|---|---|
| Receipt number | R000045599 |
| 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 |
| Date of disclosure of the study information | 2020/03/31 |
| Last modified on | 2020/03/31 09:11:43 |
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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
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
shigeaki_hayashi@jpte.co.jp
Sponsor or person
Institute
Japan Tissue Engineering Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045599
