This study involves patients with severe eye chemical burns. A chemical burn to the eye occurs when a harmful substance, such as an acid or alkali, comes into contact with the eye surface, causing damage to the tissues. In severe cases, the burn affects the entire limbus, which is the border between the clear cornea at the front of the eye and the white part of the eye, as well as the conjunctiva, which is the thin membrane covering the white part of the eye. The treatment being studied involves allogeneic bone marrow-derived mesenchymal stromal cells, which are special cells taken from the bone marrow of a donor and prepared in a laboratory. These cells are given as an injection under the conjunctiva, which is the membrane covering the eye. In addition to this main treatment, patients may receive other medications during the study, including fluorescein sodium eye drops used for eye examinations, paracetamol for pain relief, dexamethasone and oxytetracycline eye ointment that combines an anti-inflammatory medicine with an antibiotic, oxybuprocaine hydrochloride eye drops for numbing the eye, midazolam for sedation, propofol for anesthesia, human serum albumin as a protein solution, ibuprofen for pain relief, povidone iodine solution for eye cleaning, and remifentanil hydrochloride for pain control during procedures.
The purpose of this study is to evaluate how well the injection of these donor-derived cells into the area under the conjunctiva works in preserving the eyeball six months after the first injection in patients who have suffered a severe chemical burn to the eye surface in the recent past. The study will focus on patients whose chemical burn occurred within fifteen days before joining the study and whose burn is classified as very severe, affecting the entire border area around the cornea and the conjunctiva.
During the study, patients will receive the cell treatment as an injection under the membrane covering the eye. The study team will monitor the treated eye over time to check whether the cornea, which is the clear front surface of the eye, develops a hole or perforation. They will also examine other aspects of eye health, including the extent of damage to the limbal area where stem cells normally live, the degree of scarring and blood vessel growth on the cornea, signs of inflammation in the eye surface tissues, visual ability, and detailed images of the front part of the eye using specialized scanning technology. Information about any additional treatments needed and any unwanted effects will be collected from medical records and patient assessments throughout the study period.
France 
