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# Orphan Status for Chiesi Cell Therapy for Eye Condition
- URL: https://www.fdaweb.com/orphan-status-for-chiesi-cell-therapy-for-eye-condition/
- Published: 2018-06-12T12:00:00.000Z
- Updated: 2026-09-15T00:12:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141657

FDA has granted Chiesi USA an orphan drug designation for GPLSCD01, ex-vivo expanded autologous human corneal epithelial cells containing stem cells, for treating limbal stem cell deficiency. The rare and seriously debilitating condition affects one or both eyes due to physical or chemical ocular burns, inflammatory diseases, and hereditary diseases. GPLSCD01 requires a biopsy of undamaged limbus, which is then cultivated in vitro to produce a cell sheet of epithelium containing stem cells for transplantation to regenerate and repair a patient’s eye, according to the company.