SYMBOL CLINICAL : Treatment of severe ocular chemical burns by subconjunctival injection of allogeneic mesenchymal stem cells: a multicentre, single-arm, open-label phase II trial

Condition studied

Patient with severe eye chemical burns

Investigational medicinal product(s)

Eligibility

Primary endpoint

Absence of corneal perforation as assessed by the clinician

Endpoint detail

All criteria refer to the eye receiving treatment in the study: Assessed by the clinician using a fluorescein test at the slit lamp examination., All criteria refer to the eye receiving treatment in the study: Classification by the LSCD international working group, All criteria refer to the eye receiving treatment in the study: Tauber and Foster classification, All criteria refer to the eye receiving treatment in the study: Percentage of HLA-DR positive cells on conjunctival impression cytology, All criteria refer to the eye receiving treatment in the study: Snellen scale, All criteria refer to the eye receiving treatment in the study: OCT of the anterior segment (Optical Coherence Tomography), All criteria refer to the eye receiving treatment in the study: Collected from the patient's medical file, All criteria refer to the eye receiving treatment in the study: Collected from the patient's medical file, All criteria refer to the eye receiving treatment in the study: Incidence rate, type and severity of adverse events