Treatment of Severe Ocular Chemical Burns by Subconjunctival Injection of Allogeneic Mesenchymal Stem Cells: An Open-Label, Single-Arm, Multicenter Phase II Trial

Exclusion Criteria

• •Imminent corneal perforation (loss of more than two-thirds of corneal thickness)
• •Ocular infection
• •Eyelid tissue loss with permanent corneal exposure
• •Known allergy or hypersensitivity to human albumin preparations
• •History of total or partial limbal stem cell deficiency prior to the chemical injury
• •Uncontrolled glaucoma prior to the ocular burn
• •Recipient of a solid organ or cell transplant
• •Severe or uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, psychiatric, or cardiac disease, or any uncontrolled intercurrent illness
• •Active infection, including chronic or localized infections
• •History of malignancy (except completely resected localized basal cell carcinoma of the skin or cervical carcinoma in situ) within the past 5 years, whether treated or untreated, with or without evidence of recurrence or metastasis at screening
• •Current treatment with systemic immunosuppressive medications (including systemic corticosteroids, TNF-α antagonists, azathioprine, methotrexate, mycophenolate mofetil)
• •Adults under legal protection, individuals deprived of liberty by judicial or administrative decision, individuals receiving compulsory psychiatric care, or individuals admitted to a health or social care institution for purposes other than research
• •Pregnant or breastfeeding women
• •Women of childbearing potential who do not agree to use effective contraception throughout the study period (up to 12 months after the last injection)
• •Participation in another interventional clinical trial during the study follow-up period