limbal stem-cell deficiency
Conditions
Interventions
Removal of limbal tissue, EYE-01M transplantation
Sponsors
Japan Tissue Engineering Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Limbal stem-cell deficiency patients who are classified as LSCD Stage III and StageIIB that is not improved in the past three months 2) Patients who have healthy limbal of contralateral eye,and will not have trouble of tissue collection judged by principal investigator or sub-investigators 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 EYE-01M 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 EYE-01M transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy 1) case number of each LSCD staging 52 weeks after EYE-01M 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 EYE-01M transplantation or at the date of termination Safety 1) Safety endpoint i. SPK ii. corneal epithelial defect 2) Adverse events and Product-related adverse events 3) Severe product-related adverse events | — |
Countries
Japan
Contacts
Public ContactOoshima Kanji
Japan Tissue Engineering Co.,Ltd. Clinical Development Dept.
Outcome results
None listed