limbal stem-cell deficiency
Conditions
Interventions
Removal of oral mucosal tissue, COMET01 transplantation
Sponsors
Department of Ophthalmology, Osaka University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| success rate of corneal epithelium reconstruction 52 weeks after COMET01 transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactYoshinori Oie
Osaka University Graduate School of Medicine Department of Ophthalmology
Outcome results
None listed