Cord Blood Platelet-Poor Plasma In The Treatment Of Severe Dry Eye Disease: Preliminary Results From The Cb3p-Ed Randomized Clinical Trial
Published 2026 - 44th Congress of the ESCRS
Reference: FP26.05 | Type: Free paper | DOI: 10.82333/cn86-ph96
Authors: Dr Gaia Leone* 1 , Dr Daniela Galimberti 1 , Dr Marco Nassisi 1 , A/Prof. Francesco Viola 1 , Dr Guido Galmozzi 1 , Dr Laura Dell'Arti 1 , Dr Stefania Villa 1 , Dr Elena Beatrice Coluccio 1 , Dr Tiziana Montemurro 1 , Claudia Mainetti 1 , Manlio Lorenzo Martinelli 1 , Dr Giuseppa Tancredi 2
1Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico,Milan,Italy, 2Sciacca Cord Blood Bank,Presidio Ospedaliero "Giovanni Paolo II",Sciacca,Italy
Purpose
To present preliminary data from the clinical trial “Cord Blood Platelet-Poor Plasma Eye Drops (CB3P-ED)” for the treatment of severe dry eye disease (DED) associated with autoimmune disorders, including primary or secondary Sjögren’s syndrome and systemic sclerosis.
Severe DED management relies on topical immunomodulatory therapy, such as cyclosporine, and non-transfusional blood-derived products for topical use (autologous or allogeneic serum, platelet lysate). Previous studies have demonstrated the efficacy and superiority of cord blood–derived serum compared with autologous serum; however, no studies have compared these products with artificial tears
Setting
Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy, Ophthalmology Unit, (Ocular Immunology Clinic), and Transfusion Medicine Unit, for patient randomization, product storage and distribution, and collection of patient diaries.
The Sicilian Cord Blood Bank (SCBB), member of the Italian Cord Blood Bank Network (ITCBN), for the preparation of the investigational treatment (CB-PPP-ED) and for the packaging of 0.15% hyaluronic acid eye drops.
Methods
Non-profit,non-pharmacological,interventional,randomized,double-blind,single-center,crossover clinical trial conducted at the Ophthalmology Unit of Fondazione Ca’ Granda Policlinico.Fifty patients(out of 100)with severe autoimmune-related DED were enrolled and randomized 1:1 to receive either CB3P-ED(Group A)or 0.15% hyaluronic acid(Group B)for 2 months.After crossover,patients were treated for an additional month and then returned to their pre-study therapy.Assessments included ophthalmic examination,tear break-up time,fluorescein and lissamine green staining,inflammaDry test,confocal microscopy and pregnancy testing in women of childbearing potential.Symptoms were evaluated using the Ocular Surface Disease Index and visual analog scale
Results
Preliminary results demonstrate the superiority of CB3P-ED compared with artificial tears in the management of severe DED.
No adverse events were recorded in patients treated with CB3P-ED. In the control group, two patients discontinued treatment after the first study week due to worsening OSDI scores and corneal epithelial damage graded by the Oxford scale. One patient discontinued the study due to recurrence of anterior uveitis at the month 2 visit; the condition had been present prior to trial enrollment.
The exit visit of the last patient was completed on February 12, 2026, and full data analysis of the entire study cohort is currently underway.
Conclusions
Preliminary data indicate a favorable safety profile of CB3P-ED. Complete data analysis at the end of the study will be essential to confirm the clinical efficacy of this treatment and to more robustly compare its benefits with conventional therapies for severe dry eye disease