Clinical evaluation of allogeneic eye drops from cord blood platelet lysate.

BACKGROUND: Current treatments for several corneal lesions show limited efficacy. Here we report the clinical evaluation of the efficacy of a novel eye drop preparation produced in a public cord blood (CB) bank. MATERIALS AND METHODS: In a multicentre, retrospective, consecutive case study we evaluated 33 patients (46 eyes) unresponsive to conventional treatments who required urgent intervention. The patients were given allogeneic eye drops obtained from cord blood platelet lysate (CBED) to treat severe ocular surface lesions under a compassionate use protocol. The CBED were prepared from CB units donated for haematopoietic stem cell transplantation that did not contain the minimum stem cell dose required for this use. Patients were grouped by acute conditions (neurotrophic ulcers: group I; other corneal ulcers: group II; corneal burns: group III), and chronic conditions (ocular graft-versus-host disease: group IV; severe dry eye syndrome: group V). The patients received one or two drops of the product to the affected eye four to six times per day for 19 days. A further 19-day cycle of treatment could be repeated according to the initial clinical response. RESULTS: Patients received a median of 19 CBED vials (interquartile range 19-57, range 19-442) to complete the therapy. Group I-II-III patients showed full and partial ulcer recovery in 25 (78%) and six (19%) eyes respectively. One eye (3%) did not respond to treatment. For groups IV-V improvement was reported for 12 (85%) eyes and lesions worsened on treatment in both eyes (15%) of one patient. No severe adverse events were directly attributed to CBED. DISCUSSION: Promptly available CBED resulted in a well-tolerated allogeneic treatment that showed evidence of efficacy in this cohort of patients. These positive results support further studies on CBED from platelet lysate as a novel product of CB banks. A prospective clinical trial in neurotrophic keratitis (NCT03084861) is ongoing to confirm these preliminary data.

Total regression of extensive conjunctival intraepithelial neoplasia with superficial corneal invasion treated with topical mitomycin C 0.02%.

OBJECTIVE: To report complete resolution of extensive conjunctival intraepithelial neoplasia in a patient treated with topical mitomycin C. METHODS: Based on clinical examination, impression cytology was performed on the corneal-conjunctival lesion. Management consisted of topical mitomycin 0.02%, administered four times a day for four 1-week cycles, with 1 week off between cycles. RESULTS: Complete resolution of the neoplasm was observed by slit lamp examination at 5 weeks of treatment, and histological resolution by 7 weeks of treatment. There were no complications due to the use of mitomycin. CONCLUSIONS: Topical mitomycin C 2 mg/ml (0.02%) may be a safe and effective treatment for conjunctival intraepithelial neoplasm prior to surgical removal.