Clinical trial of cultivated autologous oral mucosal epithelial cell sheet transplantation for corneal epithelial stem cell deficiency
Not Applicable
- Registration Number
- JPRN-UMIN000005400
- 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
- 10
Inclusion Criteria
Not provided
Exclusion Criteria
1) Subjects who are pregnant, plan to become pregnant, or are breast-feeding. 2) Subjects who have systemic infections (HBV, HCV, HIV, HTLV-1) 3) Subjects who have extremely severe dry eye 4) Subjects who have extensive oral mucosal scarring and impossibile to obtain the oral mucosal tissue. 5) Subjects whose performance status is scored over 3 points. 6) Subjects who are not unsuitable for this project by some complications (judged by the docter in charge).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate a size of epithelial defect and conjunctivalized corneal surface area in first postoperative year.
- Secondary Outcome Measures
Name Time Method 1. Improved visual acuity 2. Improved corneal opacity 3. Improved corneal neovascularization 4. Expected eye complications 5. All adverse events