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

Phase 1

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

• Registration Number: JPRN-UMIN000012819
• Lead Sponsor: Kyoto Prefectural University of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-16
• Study Completion: 2017-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified