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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018662
Receipt No. R000021510
Scientific Title 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 2015/08/13
Last modified on 2018/02/15

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Basic information
Public title Multicenter Investigator-initiated clinical trial using cultivated autologous oral mucosal epithelial cell sheet (COMET01) transplantation for patients with limbal stem-cell deficiency
Acronym Multicenter Investigator-initiated clinical trial using COMET01 for patients with limbal stem-cell deficiency
Scientific Title 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 Multicenter Investigator-initiated clinical trial using COMET01 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 oral mucosal epithelial cell sheet (COMET01) 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 COMET01 transplantation
Key secondary outcomes Efficacy
1) case number of each LSCD staging 52 weeks after COMET01 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 COMET01 transplantation or at the date of termination
9) LSCD staging, subjective symptom, visual acuity, corneal opacity, corneal neovascularization, and symblepharon of fellow eye

Safety
1) Safety endpoint
i. SPK
ii. corneal epithelial defect
iii. keratinization
iv. conjunctival injection
v. infectious keratitis
vi. endophthalmitis
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 oral mucosal tissue, COMET01 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
2) Patients who don't have extensive oral mucosal scarring and have healthy oral mucosal tissue for harvest.
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 COMET01 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 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kohji Nishida
Organization Osaka University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code
Address 2-2, Yamada-oka, Suita, Osaka
TEL +81-6-6879-3451
Email knishida@ophthal.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinori Oie
Organization Osaka University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code
Address 2-2, Yamada-oka, Suita, Osaka
TEL +81-6-6879-3456
Homepage URL
Email yoie@ophthal.med.osaka-u.ac.jp

Sponsor
Institute Department of Ophthalmology, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 大阪大学医学部附属病院(大阪府)
東北大学病院(宮城県)
東京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 13 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
2015 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 13 Day
Last modified on
2018 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021510

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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