Clinical Study on Cultivated Autologous Oral Mucosal Epithelial Sheet Transplantation for Treating Patients with Intractable Keratoconjunctival Disease

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000012819
• Date of registration: 16/01/2014
• Prospective Registration: Yes
• Primary sponsor: Kyoto Prefectural University of Medicine
• Public title: Clinical Study on Cultivated Autologous Oral Mucosal Epithelial Sheet Transplantation for Treating Patients with Intractable Keratoconjunctival Disease
• Scientific title: Clinical Study on Cultivated Autologous Oral Mucosal Epithelial Sheet Transplantation for Treating Patients with Intractable Keratoconjunctival Disease - Cultivated Autologous Oral Mucosal Epithelial Sheet Transplantation
• Date of first enrolment: 2014/01/23
• Target sample size: 30
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014978
• Study type: Interventional
• Study design: Single arm Non-randomized
• Phase: Phase I,II

Countries of recruitment

Japan

Contacts

• Name: Chie Sotozono, M.D., Ph.D.
• Affiliation: Kyoto Prefectural University of Medicine Department of Ophthalmology

• Name: Shigeru Kinoshita, M.D., Ph.D.
• Affiliation: Kyoto Prefectural University of Medicine Department of Ophthalmology

Key inclusion & exclusion criteria

Inclusion criteria:
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.

Age minimum: 15years-old
Age maximum: 85years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Patients with keratoconjunctival disease (Stevens-Johnson syndrome, ocular pemphigoid, or severe thermal/chemical injury)

Intervention(s)

Corneal reconstruction (improvement of vision and epithelial repair) Conjunctival sac reconstruction (adhesion separation)

Primary Outcome(s)

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.

Secondary Outcome(s)

<Objective findings> Each item in ophthalmology findings A and B. <Safety Evaluation> Incidence rates and severities of adverse events.

Secondary ID(s)

TRIOPH1007

Source(s) of Monetary Support

Ministry of Education, Culture, Sports, Science and Technology

Ministry of Health, Labour and Welfare

Secondary Sponsor(s)

Foundation for Biomedical Research and Innovation

Ethics review

Status: YES
Approval date:
Contact:

Results

• Results available: Yes
• Date Completed: 31/03/2017