Multicenter Investigator-initiated clinical trial using cultivated autologous oral mucosal epithelial cell sheet (COMET01) transplantation for patients with limbal stem-cell deficiency
- Conditions
- limbal stem-cell deficiency
- Registration Number
- JPRN-UMIN000018662
- Lead Sponsor
- Department of Ophthalmology, Osaka University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 6
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method