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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012819
Receipt No. R000014978
Scientific Title Clinical Study on Cultivated Autologous Oral Mucosal Epithelial Sheet Transplantation for Treating Patients with Intractable Keratoconjunctival Disease
Date of disclosure of the study information 2014/01/16
Last modified on 2017/08/09

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Basic information
Public title Clinical Study on Cultivated Autologous Oral Mucosal Epithelial Sheet Transplantation for Treating Patients with Intractable Keratoconjunctival Disease
Acronym Cultivated Autologous Oral Mucosal Epithelial Sheet Transplantation
Scientific Title Clinical Study on Cultivated Autologous Oral Mucosal Epithelial Sheet Transplantation for Treating Patients with Intractable Keratoconjunctival Disease
Scientific Title:Acronym Cultivated Autologous Oral Mucosal Epithelial Sheet Transplantation
Region
Japan

Condition
Condition Patients with keratoconjunctival disease
(Stevens-Johnson syndrome, ocular pemphigoid, or severe thermal/chemical injury)
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aims of this clinical study on cultivated autologous oral mucosal epithelial sheet transplantation for patients with intractable keratoconjunctival disease (hereinafter referred to as the "present study") are as follows: 1) to check the safety of cultivated autologous oral mucosal epithelial sheet transplantation for patients with severe stem cell deficiency who are afflicted with the most severe degree of an intractable keratoconjunctival disease which is difficult to treat using any method, 2) to improve abnormalities on the ocular surface (corneal opacity, epithelial defects, and ocular surface adhesion), and 3) to investigate the efficacy of ocular surface restoration, which is further categorized into corneal restoration and conjunctival restoration.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes 1)Change in distance vision (5 meters) from before transplantation to postoperative Week 24.
2)Change in total epithelial abnormality score (out of the total ophthalmological findings A score, the total score for epithelial defects, conjunctival invasion, and vascular invasion) from before transplantation to postoperative Week 24.
3)Change in conjunctival sac adhesion score (total of scores for upper and lower) within ophthalmological findings A from before transplantation to postoperative Week 24.

The purpose of transplantation is either improvement of vision, repairing epithelial defects, or detaching ocular surface adhesion. The primary endpoints are the scores for changes in vision, changes in total epithelial abnormality scores, and conjunctival sac adhesion score for each purpose.
Key secondary outcomes <Objective findings>
Each item in ophthalmology findings A and B.
<Safety Evaluation>
Incidence rates and severities of 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 Maneuver
Interventions/Control_1 Corneal reconstruction (improvement of vision and epithelial repair)
Conjunctival sac reconstruction (adhesion separation)
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
15 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria 1) Being diagnosed with intractable keratoconjunctival disease due to the following diseases: a) Stevens Johnson syndrome, b) ocular pemphigoid, or c) severe thermal/chemical injury).
2) Afflicted with a bilateral disease with no availability of a therapeutic option that utilizes autologous tissue transplantation.
3) Being 15 years of age or older and younger than 86 years of age at the time of obtaining informed consent.
4) Patients undergoing transplantation for the purpose of recovering vision, improving epithelial defects, or improving ocular surface adhesion. In addition, scores and values for each purpose at the time of registration are as follows:
Improvement of vision: Patients with decimal visual acuity of less than 0.1.
Improvement of epithelial defects: Patients with a total score value for epithelial defects, conjunctival invasion, and vascular invasion of 3 or higher. These are the three ophthalmological findings scores stipulated in the present study.
Detachment of ocular surface adhesion: Patients with 50% or greater adhesion either on the upper or lower conjunctival sac.
5) Patients or their representatives (both the patient and their representative if the patient is between 15 and 20 years of age) from whom written informed consent is obtained.
Key exclusion criteria 1) Having an active corneal infection.
2) Having glaucoma with insufficient ocular pressure control.
3) Patients diagnosed as being complicated with, or carriers of, any of the following diseases: HBV, HCV, HIV, HTLV, or syphilis.
4) Diabetic patients with insufficient glucose control.
5) Patients who are hypersensitive to cyclosporine or steroids.
6) Pregnant women, female patients who have expressed their desire to become pregnant during the course of the study, or those who are currently breastfeeding a child.
7) Patients for whom participation in the present study is believed to be inappropriate due to personal complications or other reasons.
8) Patients who have been diagnosed with any of the following intractable keratoconjunctival diseases: severe recurring pterygium, aniridia, cicatricial pemphigoid, and stem cell deficiency due to drug toxicity or due to an unknown cause.
9) Patients complicated with systemic autoimmune diseases.
10) Patients with visual impairment which is strongly suspected to be affected by other causes.
11) Patients who have already undergone the present protocol treatment.
12) Patients who are currently using or are planning to use anti-cancer agents.
13) Patients with a past history (or those complicated with) cardiac diseases, or cerebrovascular disorders.
14) Patients with impaired eyelid closure due to eyelid function disorders if the purpose of treatment is corneal reconstruction (the purpose of recovering vision or repairing the epithelium).
15) Patients for whom it has been determined that it is difficult to collect the oral cavity mucosal tissue which is required for creating the test material for the present study.
16) Patients for whom it has been determined by the principal investigator or other researchers that there will be complicating issues with the patient participating in the study for other reasons.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Kinoshita, M.D., Ph.D.
Organization Kyoto Prefectural University of Medicine
Division name Department of Ophthalmology
Zip code
Address 465 Kajii-cho, Hirokoji-agaru, Kawaramachi-dori, Kamigyo-ku, Kyoto, Japan
TEL 075-251-5577
Email shigeruk@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chie Sotozono, M.D., Ph.D.
Organization Kyoto Prefectural University of Medicine
Division name Department of Ophthalmology
Zip code
Address 465 Kajii-cho, Hirokoji-agaru, Kawaramachi-dori, Kamigyo-ku, Kyoto, Japan
TEL 075-251-5577
Homepage URL
Email csotozon@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Foundation for Biomedical Research and Innovation
Name of secondary funder(s) Ministry of Education, Culture, Sports, Science and Technology

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 TRIOPH1007
Org. issuing International ID_1 Translational Research Informatics Center, Foundation for Biomedical Research and Innovation
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 京都府立医科大学病院(京都府)
(公財)先端医療振興財団先端医療センター病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 16 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
2013 Year 09 Month 13 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 23 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 01 Month 10 Day
Last modified on
2017 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014978

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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