Exploratory clinical trial of serum-, and feeder cell-free cultivated autologous corneal limbal epithelial cell sheet transplantation using human amniotic membrane for corneal epithelial stem-cell deficiency
Not Applicable
- Conditions
- nilateral corneal epithelial stem cell deficiency: Patients who have dysfunction of the entire limbus with almost replaced by conjunctival epithelium, neovascularization and corneal scarring tissue.
- Registration Number
- JPRN-UMIN000012014
- Lead Sponsor
- Department of Ophthalmology, Graduate School of Medicine, The University of Tokyo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 3
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 has not passed for six months after undergoing the next operation on the eye which is due to be transplanted; conjunctival sac plasty, amnion transplant of sclera, mitomycin-C treatment 5) 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 the existence of omission of the transplanted cell sheet, expected eye complications, and all adverse events including a laboratory test abnormality
- Secondary Outcome Measures
Name Time Method 1. To evaluate the area without epithelial defect or conjunctivalization 2. Improved visual acuity 3. Improved corneal opacity 4. Improved corneal neovascularization