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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039992
Receipt No. R000045597
Scientific Title Long-term follow-up of the multicenter investigator-initiated clinical trial using cultivated autologous oral mucosal epithelial cell sheet (COMET01) transplantation for patients with limbal stem-cell deficiency
Date of disclosure of the study information 2020/03/31
Last modified on 2020/03/31

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Basic information
Public title Long-term follow-up of the multicenter investigator-initiated clinical trial using cultivated autologous oral mucosal epithelial cell sheet (COMET01) transplantation for patients with limbal stem-cell deficiency
Acronym Long-term follow-up of the multicenter investigator-initiated clinical trial using cultivated autologous oral mucosal epithelial cell sheet (COMET01) transplantation for patients with limbal stem-cell deficiency
Scientific Title Long-term follow-up of the multicenter investigator-initiated clinical trial using cultivated autologous oral mucosal epithelial cell sheet (COMET01) transplantation for patients with limbal stem-cell deficiency
Scientific Title:Acronym Long-term follow-up of the multicenter investigator-initiated clinical trial using cultivated autologous oral mucosal epithelial cell sheet (COMET01) 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 cultivated autologous oral mucosal epithelial cell sheet (COMET01) have been transplanted in the clinical study (protocol No. OUH-COMET01).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) LSCD staging for 104 weeks after COMET01 transplantation
Key secondary outcomes Efficacy
2) LSCD staging after COMET01 transplantation
3) Subjective symptom
4) Visual acuity
5) QOL
6) Corneal opacity
7) Corneal neovascularization
8) Symblepharon
9) Contributing to the regeneration corneal epithelium in patients with additional therapy
10) LSCD staging, subjective symptom, visual acuity, corneal opacity, corneal neovascularization, and symblepharon of fellow eye
* This study makes no distinction between primary and secondary efficacy endpoints

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 COMET01 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 COMET01 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 6

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 443-0022
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 Masami
Middle name
Last name Suzuki
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 masami_suzuki@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 2-15 Yamadaoka, Suita, Osaka 565-0871
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 6
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 09 Month 08 Day
Date of IRB
2017 Year 01 Month 23 Day
Anticipated trial start date
2016 Year 11 Month 18 Day
Last follow-up date
2018 Year 08 Month 17 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 COMET01 study(UMIN000018662)

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=R000045597

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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