Abstract 11 Outcome of Patients Treated with Umbilical Cord Blood and Homologous Serum Eye Drops

INTRODUCTION: Several authors have demonstrated the safety and efficacy of CBS eye drops in the treatment of severe DE with or without Sjogren’s syndrome (SS-I), ocular graft versus host disease (GVHD), persistent corneal epithelial defects, recurrent corneal erosions, chemical burns, and neurotrophic keratitis. OBJECTIVE: To compare the efficacy of cord blood serum (CBS) and adult donor peripheral blood serum (PBS) eye drops (prepared, standardized, and controlled in the Emilia Romagna Cord Blood Bank) in the treatment of severe dry eye disease (DED), a multicenter randomized, double masked, crossover clinical trial was designed. METHODS: Sixty patients diagnosed with severe DED associated with persistent corneal epithelial defects were randomized and equally assigned to group A (treated with CBS) or group B (treated with PBS) , eye drops administered 8 times/day for 1 month. Primary outcome was the pre-treatment and post-treatment change in corneal fluorescein staining. Secondary outcomes included the pretreatment and post-treatment change in ocular surface disease index (OSDI), questionnaire and Visual Analogue Score (VAS) of subjective symptoms, Schirmer I test, tear break-up time, and conjunctival staining. Patients with relapse in signs or symptoms after further 2 months switched to the remaining group for one additional month. RESULTS: Corneal staining was more significantly reduced after CBS treatment; both VAS and OSDI score reduction was observed in both groups, but group A reported significantly less grittiness and pain. Nineteen patients shifted in the crossover period. The within individual comparison confirmed a better recovery in the CBS treatment period. Epidermal growth factor, transforming growth factor, and platelet-derived growth factor content was associated with reduction of epithelial damage. Levels of interleukins were positively associated with symptoms decrease. DISCUSSION: DED signs improved after both CBS and PBS treatments with potential advantages of CBS for subjective symptoms and corneal damage reduction. In addition to the very important therapeutic value of EDHO products, considering the CB units not suitable for transplantation, we have identified novel non-wasteful clinical applications of those allogeneic biological products, resulting in an increase of ethical motivation of families generously donating CB for public benefit.