Unique ID issued by UMIN | UMIN000012819 |
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Receipt number | 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 11:15:02 |
Clinical Study on Cultivated Autologous Oral Mucosal Epithelial Sheet Transplantation for Treating Patients with Intractable Keratoconjunctival Disease
Cultivated Autologous Oral Mucosal Epithelial Sheet Transplantation
Clinical Study on Cultivated Autologous Oral Mucosal Epithelial Sheet Transplantation for Treating Patients with Intractable Keratoconjunctival Disease
Cultivated Autologous Oral Mucosal Epithelial Sheet Transplantation
Japan |
Patients with keratoconjunctival disease
(Stevens-Johnson syndrome, ocular pemphigoid, or severe thermal/chemical injury)
Ophthalmology |
Others
NO
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.
Safety,Efficacy
Exploratory
Pragmatic
Phase I,II
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.
<Objective findings>
Each item in ophthalmology findings A and B.
<Safety Evaluation>
Incidence rates and severities of adverse events.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment | Maneuver |
Corneal reconstruction (improvement of vision and epithelial repair)
Conjunctival sac reconstruction (adhesion separation)
15 | years-old | <= |
85 | years-old | > |
Male and Female
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.
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.
30
1st name | |
Middle name | |
Last name | Shigeru Kinoshita, M.D., Ph.D. |
Kyoto Prefectural University of Medicine
Department of Ophthalmology
465 Kajii-cho, Hirokoji-agaru, Kawaramachi-dori, Kamigyo-ku, Kyoto, Japan
075-251-5577
shigeruk@koto.kpu-m.ac.jp
1st name | |
Middle name | |
Last name | Chie Sotozono, M.D., Ph.D. |
Kyoto Prefectural University of Medicine
Department of Ophthalmology
465 Kajii-cho, Hirokoji-agaru, Kawaramachi-dori, Kamigyo-ku, Kyoto, Japan
075-251-5577
csotozon@koto.kpu-m.ac.jp
Kyoto Prefectural University of Medicine
Ministry of Health, Labour and Welfare
Japanese Governmental office
Foundation for Biomedical Research and Innovation
Ministry of Education, Culture, Sports, Science and Technology
YES
TRIOPH1007
Translational Research Informatics Center, Foundation for Biomedical Research and Innovation
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)
2014 | Year | 01 | Month | 16 | Day |
Unpublished
Completed
2013 | Year | 09 | Month | 13 | Day |
2014 | Year | 01 | Month | 23 | Day |
2017 | Year | 03 | Month | 31 | Day |
2014 | Year | 01 | Month | 10 | Day |
2017 | Year | 08 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014978
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